2.04.26 Fecal Analysis in the Diagnosis of Intestinal ...
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MEDICAL POLICY – 2.04.26 Fecal Analysis in the Diagnosis of Intestinal Dysbiosis and Irritable Bowel Syndrome BCBSA Ref. Policy: 2.04.26 Effective Date: July 1, 2021 Last Revised: June 8, 2021 Replaces: N/A RELATED MEDICAL POLICIES: None Select a hyperlink below to be directed to that section. POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction Intestinal dysbiosis is a condition that occurs when the microorganisms in the digestive tract are out of balance. This condition is believed to cause diseases of the digestive tract, including poor nutrient absorption, overgrowth of certain bacteria, and irritable bowel syndrome (IBS). Symptoms of these digestive problems are similar and may include: abdominal pain, excess gas, bloating, and changes in bowel movements (constipation or diarrhea, or both). One method of diagnosing digestive disorders is by testing a fecal sample. Using fecal analysis to diagnose intestinal dysbiosis, IBS, malabsorption, or small intestinal overgrowth of bacteria is unproven (investigational). More studies are needed to see if this testing improves health outcomes. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria
Transcript of 2.04.26 Fecal Analysis in the Diagnosis of Intestinal ...
2.04.26 Fecal Analysis in the Diagnosis of Intestinal Dysbiosis and
Irritable Bowel SyndromeMEDICAL POLICY – 2.04.26 Fecal Analysis in
the Diagnosis of Intestinal Dysbiosis and Irritable Bowel Syndrome
BCBSA Ref. Policy: 2.04.26 Effective Date: July 1, 2021 Last
Revised: June 8, 2021 Replaces: N/A
RELATED MEDICAL POLICIES: None
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY
∞ Clicking this icon returns you to the hyperlinks menu above.
Introduction
Intestinal dysbiosis is a condition that occurs when the microorganisms in the digestive tract are out of balance. This condition is believed to cause diseases of the digestive tract, including poor nutrient absorption, overgrowth of certain bacteria, and irritable bowel syndrome (IBS). Symptoms of these digestive problems are similar and may include: abdominal pain, excess gas, bloating, and changes in bowel movements (constipation or diarrhea, or both). One method of diagnosing digestive disorders is by testing a fecal sample. Using fecal analysis to diagnose intestinal dysbiosis, IBS, malabsorption, or small intestinal overgrowth of bacteria is unproven (investigational). More studies are needed to see if this testing improves health outcomes.
Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.
Policy Coverage Criteria
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Test Investigational Examples: (this list may not be all inclusive) • GI effects®
Comprehensive Stool Profile (Genova)
Fecal analysis of the following components is considered investigational as a diagnostic test for the evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal overgrowth of bacteria: • Cholesterol • Chymotrypsin • Fecal secretory immunoglobulin A • Identification and quantitation of fecal yeast (including Candida
albicans, Candida tropicalis, Rhodotorula, and Geotrichum) • Iso-butyrate, iso-valerate, and n-valerate • Levels of Lactobacilli, bifidobacteria, and Escherichiacoli and
other “potential pathogens,” including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, Staphylococcus aureus, and Vibrio
• Long-chain fatty acids • Meat and vegetable fibers • N-butyrate • pH • Short-chain fatty acid distribution (adequate amount and
proportions of the different short-chain fatty acids reflect the basic status of intestinal metabolism)
• Total short-chain fatty acids • Triglycerides • β -glucuronidase
Coding
The following CPT codes may be used to identify individual components of fecal analysis
Code Description CPT
82271 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; other sources
82272 Blood, occult, by peroxidase activity (eg, guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening
82274 Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations
82542 Column chromatography, includes mass spectrometry, if performed (eg, HPLC, LC, LC/MS, LC/MS-MS, GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen
82656 Elastase, pancreatic (EL-1), fecal, qualitative or semi-quantitative
82710 Fat or lipids, feces; quantitative
82715 Fat differential, feces, quantitative
82725 Fatty acids, nonesterified
82784 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each
83520 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified
83630 Lactoferrin, fecal; qualitative
83993 Calprotectin, fecal
87045 Culture, bacterial; stool, aerobic, with isolation and preliminary examination (eg, KIA, LIA), Salmonella and Shigella species
87046 Culture, bacterial; stool, aerobic, additional pathogens, isolation and presumptive identification of isolates, each plate
87075 Culture, bacterial; any source, except blood, anaerobic with isolation and presumptive identification of isolates
87102 Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; other source (except blood)
87177 Ova and parasites, direct smears, concentration and identification
87209 Smear, primary source with interpretation; complex special stain (eg, trichrome, iron hemotoxylin) for ova and parasites
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immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Clostridium difficile toxin(s)
87427 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Shiga-like toxin
87328 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; cryptosporidium
87329 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; giardia
87336 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Entamoeba histolytica dispar group
87338 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Helicobacter pylori, stool
87449 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; not otherwise specified, each organism
87505 Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets
87798 Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism
89160 Meat fibers, feces
HCPCS Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
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Related Information
Benefit Application
Due to the nonspecific nature of the CPT codes used to identify different components of fecal analysis, identification of these claims may require identification of those laboratories that specialize in the analysis for the evaluation of intestinal dysbiosis. Because there are a limited number of laboratories that provide this type of fecal analysis, these services may be provided by out-of-network providers. Also, a review of these services may be approached through a retrospective review looking for specific patterns of testing.
Evidence Review
Description
Intestinal dysbiosis may be defined as a state of disordered microbial ecology that is believed to cause disease. Laboratory analysis of fecal samples is proposed as a method of identifying individuals with intestinal dysbiosis and other gastrointestinal disorders.
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder that affects 10% to 20% of the general population in the U.S. and worldwide. Symptoms include abdominal pain and/or bloating associated with disordered bowel habit (constipation, diarrhea, or both). Pathophysiology is poorly understood but may be related to chronic low-grade mucosal inflammation and disturbances in GI flora. Recommended treatments include dietary restriction and pharmacologic symptom control. As living microorganisms that promote health when administered to a host in therapeutic doses, probiotics are being investigated as a treatment for IBS. Several systematic reviews of randomized controlled trials have found evidence to support efficacy but results from recent randomized controlled trials have been mixed. This discrepancy may be due in part to the differential effects of different probiotic strains and doses.
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Fecal Markers of Dysbiosis
Laboratory analysis of both stool and urine has been investigated as markers of dysbiosis. Commercial laboratories may offer testing for comprehensive panels or individual components of various aspects of digestion, absorption, microbiology, and metabolic markers. Representative components of fecal dysbiosis testing are summarized in Table 1.
Table 1. Components of the Fecal Dysbiosis Marker Analysis
Markers Analytes Digestion • Triglycerides
• Identification and quantitation of fecal yeast (including Candida albicans, Candida tropicalis, Rhodotorula, and Geotrichum) (optional viral and/or parasitology components)
Metabolic • N-butyrate (considered key energy source for colonic epithelial cells)
• β-glucuronidase
• pH
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Markers Analytes Short-chain fatty acid distribution (adequate amount and proportions of the different short-chain fatty acids reflect the basic status of intestinal metabolism)
Immunology • Fecal secretory immunoglobulin A (as a measure of luminal immunologic function)
• Calprotectina
a Fecal calprotectin as a stand-alone test is not addressed in this policy.
Fecal Testing for Intestinal Dysbiosis
The gastrointestinal tract is colonized by a large number and a variety of microorganisms including bacteria, fungi, and archaea. The concept of intestinal dysbiosis rests on the assumption that abnormal patterns of intestinal flora, such as overgrowth of some commonly found microorganisms, have an impact on human health. Symptoms and conditions attributed to intestinal dysbiosis in addition to gastrointestinal disorders include chronic disorders (eg, irritable bowel syndrome [IBS], inflammatory or autoimmune disorders, food allergy, atopic eczema, unexplained fatigue, arthritis, ankylosing spondylitis), malnutrition, or neuropsychiatric symptoms or neurodevelopmental conditions (eg, autism), and breast and colon cancer.
The gastrointestinal tract symptoms attributed to intestinal dysbiosis (ie, bloating, flatulence, diarrhea, constipation) overlap in part with either IBS or small intestinal bacterial overgrowth syndrome. The diagnosis of IBS is typically made clinically, based on a set of criteria referred to as the Rome criteria. The small intestine normally contains a limited number of bacteria, at least as compared with the large intestine. Small intestine bacterial overgrowth may occur due to altered motility (including blind loops), decreased acidity, exposure to antibiotics, or surgical resection of the small bowel. Symptoms include malabsorption, diarrhea, fatigue, and lethargy. The laboratory criterion standard for diagnosis consists of the culture of a jejunal fluid sample, but this requires invasive testing. Hydrogen breath tests, commonly used to evaluate lactose intolerance, have been adapted for use in diagnosing small intestinal bacterial overgrowth.
The GI Effects Comprehensive Stool Profile (Genova Diagnostics) is a multianalyte stool assay.2 The test uses polymerase chain reaction (PCR) to quantify 26 commensal gut bacteria and standard biochemical and culture methods to measure levels of other stool components (eg, lipids, fecal occult blood) and potential pathogens (ova and parasites, opportunistic bacteria, yeast). The test is purported to optimize management of gut health and to differentiate IBS from inflammatory bowel disease (IBD).
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Summary of Evidence
For individuals who have gastrointestinal conditions such as suspected intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal bacterial overgrowth who receive fecal analysis testing, the evidence includes several cohort and case-control studies comparing fecal microbiota in patients who had a known disease with healthy controls. Relevant outcomes are test validity, symptoms, and functional outcomes. The available retrospective cohort studies on fecal analysis have suggested that some components of the fecal microbiome and inflammatory markers may differ across patients with irritable bowel syndrome subtypes. No studies were identified on the diagnostic accuracy of fecal analysis vs another diagnostic approach or that compared health outcomes in patients managed with and without fecal analysis tests. No studies were identified that directly informed the use of fecal analysis in the evaluation of intestinal dysbiosis, malabsorption, or small intestinal bacterial overgrowth. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.
No studies were identified that assessed the accuracy of the GI Effects fecal panel for diagnosing IBS or for documenting "gut health," a concept that may be difficult to define given large interindividual variability in gut flora. Evidence for the clinical validity and utility of the GI Effects Comprehensive Stool Profile is lacking. Because probiotics are not currently a standard treatment of IBS, the impact of test results on disease management is uncertain; ie, a chain of evidence for clinical utility of the test cannot be established.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in November 2020 did not identify any ongoing or unpublished trials that would likely influence this review.
Practice Guidelines and Position Statements
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Regulatory Status
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of comprehensive testing for fecal dysbiosis.
References
1. Emmanuel A, Landis D, Peucker M, et al. Faecal biomarker patterns in patients with symptoms of irritable bowel syndrome. Frontline Gastroenterol. Oct 2016; 7(4): 275-282. PMID 27761231
2. Genova Diagnostics. 2015; www.gdx.net. Accessed June 16, 2021.
3. Goepp J, Fowler E, McBride T, et al. Frequency of abnormal fecal biomarkers in irritable bowel syndrome. Glob Adv Health Med. May 2014; 3(3): 9-15. PMID 24891989
4. Andoh A, Kuzuoka H, Tsujikawa T, et al. Multicenter analysis of fecal microbiota profiles in Japanese patients with Crohn's disease. J Gastroenterol. Dec 2012; 47(12): 1298-307. PMID 22576027
5. Sobhani I, Tap J, Roudot-Thoraval F, et al. Microbial dysbiosis in colorectal cancer (CRC) patients. PLoS One. Jan 27 2011; 6(1): e16393. PMID 21297998
6. Joossens M, Huys G, Cnockaert M, et al. Dysbiosis of the faecal microbiota in patients with Crohn's disease and their unaffected relatives. Gut. May 2011; 60(5): 631-7. PMID 21209126
7. Langhorst J, Elsenbruch S, Koelzer J, et al. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol. Jan 2008; 103(1): 162-9. PMID 17916108
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Date Comments 07/01/21 New policy, approved June 8, 2021. Fecal analysis in the diagnosis of intestinal dysbiosis and irritable
bowel syndrome is considered investigational.
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Introduction
Intestinal dysbiosis is a condition that occurs when the microorganisms in the digestive tract are out of balance. This condition is believed to cause diseases of the digestive tract, including poor nutrient absorption, overgrowth of certain bacteria, and irritable bowel syndrome (IBS). Symptoms of these digestive problems are similar and may include: abdominal pain, excess gas, bloating, and changes in bowel movements (constipation or diarrhea, or both). One method of diagnosing digestive disorders is by testing a fecal sample. Using fecal analysis to diagnose intestinal dysbiosis, IBS, malabsorption, or small intestinal overgrowth of bacteria is unproven (investigational). More studies are needed to see if this testing improves health outcomes.
Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.
Policy Coverage Criteria
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Test Investigational Examples: (this list may not be all inclusive) • GI effects®
Comprehensive Stool Profile (Genova)
Fecal analysis of the following components is considered investigational as a diagnostic test for the evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal overgrowth of bacteria: • Cholesterol • Chymotrypsin • Fecal secretory immunoglobulin A • Identification and quantitation of fecal yeast (including Candida
albicans, Candida tropicalis, Rhodotorula, and Geotrichum) • Iso-butyrate, iso-valerate, and n-valerate • Levels of Lactobacilli, bifidobacteria, and Escherichiacoli and
other “potential pathogens,” including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, Staphylococcus aureus, and Vibrio
• Long-chain fatty acids • Meat and vegetable fibers • N-butyrate • pH • Short-chain fatty acid distribution (adequate amount and
proportions of the different short-chain fatty acids reflect the basic status of intestinal metabolism)
• Total short-chain fatty acids • Triglycerides • β -glucuronidase
Coding
The following CPT codes may be used to identify individual components of fecal analysis
Code Description CPT
82271 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; other sources
82272 Blood, occult, by peroxidase activity (eg, guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening
82274 Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations
82542 Column chromatography, includes mass spectrometry, if performed (eg, HPLC, LC, LC/MS, LC/MS-MS, GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen
82656 Elastase, pancreatic (EL-1), fecal, qualitative or semi-quantitative
82710 Fat or lipids, feces; quantitative
82715 Fat differential, feces, quantitative
82725 Fatty acids, nonesterified
82784 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each
83520 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified
83630 Lactoferrin, fecal; qualitative
83993 Calprotectin, fecal
87045 Culture, bacterial; stool, aerobic, with isolation and preliminary examination (eg, KIA, LIA), Salmonella and Shigella species
87046 Culture, bacterial; stool, aerobic, additional pathogens, isolation and presumptive identification of isolates, each plate
87075 Culture, bacterial; any source, except blood, anaerobic with isolation and presumptive identification of isolates
87102 Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; other source (except blood)
87177 Ova and parasites, direct smears, concentration and identification
87209 Smear, primary source with interpretation; complex special stain (eg, trichrome, iron hemotoxylin) for ova and parasites
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immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Clostridium difficile toxin(s)
87427 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Shiga-like toxin
87328 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; cryptosporidium
87329 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; giardia
87336 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Entamoeba histolytica dispar group
87338 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Helicobacter pylori, stool
87449 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; not otherwise specified, each organism
87505 Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets
87798 Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism
89160 Meat fibers, feces
HCPCS Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
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Related Information
Benefit Application
Due to the nonspecific nature of the CPT codes used to identify different components of fecal analysis, identification of these claims may require identification of those laboratories that specialize in the analysis for the evaluation of intestinal dysbiosis. Because there are a limited number of laboratories that provide this type of fecal analysis, these services may be provided by out-of-network providers. Also, a review of these services may be approached through a retrospective review looking for specific patterns of testing.
Evidence Review
Description
Intestinal dysbiosis may be defined as a state of disordered microbial ecology that is believed to cause disease. Laboratory analysis of fecal samples is proposed as a method of identifying individuals with intestinal dysbiosis and other gastrointestinal disorders.
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder that affects 10% to 20% of the general population in the U.S. and worldwide. Symptoms include abdominal pain and/or bloating associated with disordered bowel habit (constipation, diarrhea, or both). Pathophysiology is poorly understood but may be related to chronic low-grade mucosal inflammation and disturbances in GI flora. Recommended treatments include dietary restriction and pharmacologic symptom control. As living microorganisms that promote health when administered to a host in therapeutic doses, probiotics are being investigated as a treatment for IBS. Several systematic reviews of randomized controlled trials have found evidence to support efficacy but results from recent randomized controlled trials have been mixed. This discrepancy may be due in part to the differential effects of different probiotic strains and doses.
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Fecal Markers of Dysbiosis
Laboratory analysis of both stool and urine has been investigated as markers of dysbiosis. Commercial laboratories may offer testing for comprehensive panels or individual components of various aspects of digestion, absorption, microbiology, and metabolic markers. Representative components of fecal dysbiosis testing are summarized in Table 1.
Table 1. Components of the Fecal Dysbiosis Marker Analysis
Markers Analytes Digestion • Triglycerides
• Identification and quantitation of fecal yeast (including Candida albicans, Candida tropicalis, Rhodotorula, and Geotrichum) (optional viral and/or parasitology components)
Metabolic • N-butyrate (considered key energy source for colonic epithelial cells)
• β-glucuronidase
• pH
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Markers Analytes Short-chain fatty acid distribution (adequate amount and proportions of the different short-chain fatty acids reflect the basic status of intestinal metabolism)
Immunology • Fecal secretory immunoglobulin A (as a measure of luminal immunologic function)
• Calprotectina
a Fecal calprotectin as a stand-alone test is not addressed in this policy.
Fecal Testing for Intestinal Dysbiosis
The gastrointestinal tract is colonized by a large number and a variety of microorganisms including bacteria, fungi, and archaea. The concept of intestinal dysbiosis rests on the assumption that abnormal patterns of intestinal flora, such as overgrowth of some commonly found microorganisms, have an impact on human health. Symptoms and conditions attributed to intestinal dysbiosis in addition to gastrointestinal disorders include chronic disorders (eg, irritable bowel syndrome [IBS], inflammatory or autoimmune disorders, food allergy, atopic eczema, unexplained fatigue, arthritis, ankylosing spondylitis), malnutrition, or neuropsychiatric symptoms or neurodevelopmental conditions (eg, autism), and breast and colon cancer.
The gastrointestinal tract symptoms attributed to intestinal dysbiosis (ie, bloating, flatulence, diarrhea, constipation) overlap in part with either IBS or small intestinal bacterial overgrowth syndrome. The diagnosis of IBS is typically made clinically, based on a set of criteria referred to as the Rome criteria. The small intestine normally contains a limited number of bacteria, at least as compared with the large intestine. Small intestine bacterial overgrowth may occur due to altered motility (including blind loops), decreased acidity, exposure to antibiotics, or surgical resection of the small bowel. Symptoms include malabsorption, diarrhea, fatigue, and lethargy. The laboratory criterion standard for diagnosis consists of the culture of a jejunal fluid sample, but this requires invasive testing. Hydrogen breath tests, commonly used to evaluate lactose intolerance, have been adapted for use in diagnosing small intestinal bacterial overgrowth.
The GI Effects Comprehensive Stool Profile (Genova Diagnostics) is a multianalyte stool assay.2 The test uses polymerase chain reaction (PCR) to quantify 26 commensal gut bacteria and standard biochemical and culture methods to measure levels of other stool components (eg, lipids, fecal occult blood) and potential pathogens (ova and parasites, opportunistic bacteria, yeast). The test is purported to optimize management of gut health and to differentiate IBS from inflammatory bowel disease (IBD).
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Summary of Evidence
For individuals who have gastrointestinal conditions such as suspected intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal bacterial overgrowth who receive fecal analysis testing, the evidence includes several cohort and case-control studies comparing fecal microbiota in patients who had a known disease with healthy controls. Relevant outcomes are test validity, symptoms, and functional outcomes. The available retrospective cohort studies on fecal analysis have suggested that some components of the fecal microbiome and inflammatory markers may differ across patients with irritable bowel syndrome subtypes. No studies were identified on the diagnostic accuracy of fecal analysis vs another diagnostic approach or that compared health outcomes in patients managed with and without fecal analysis tests. No studies were identified that directly informed the use of fecal analysis in the evaluation of intestinal dysbiosis, malabsorption, or small intestinal bacterial overgrowth. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.
No studies were identified that assessed the accuracy of the GI Effects fecal panel for diagnosing IBS or for documenting "gut health," a concept that may be difficult to define given large interindividual variability in gut flora. Evidence for the clinical validity and utility of the GI Effects Comprehensive Stool Profile is lacking. Because probiotics are not currently a standard treatment of IBS, the impact of test results on disease management is uncertain; ie, a chain of evidence for clinical utility of the test cannot be established.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in November 2020 did not identify any ongoing or unpublished trials that would likely influence this review.
Practice Guidelines and Position Statements
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Regulatory Status
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of comprehensive testing for fecal dysbiosis.
References
1. Emmanuel A, Landis D, Peucker M, et al. Faecal biomarker patterns in patients with symptoms of irritable bowel syndrome. Frontline Gastroenterol. Oct 2016; 7(4): 275-282. PMID 27761231
2. Genova Diagnostics. 2015; www.gdx.net. Accessed June 16, 2021.
3. Goepp J, Fowler E, McBride T, et al. Frequency of abnormal fecal biomarkers in irritable bowel syndrome. Glob Adv Health Med. May 2014; 3(3): 9-15. PMID 24891989
4. Andoh A, Kuzuoka H, Tsujikawa T, et al. Multicenter analysis of fecal microbiota profiles in Japanese patients with Crohn's disease. J Gastroenterol. Dec 2012; 47(12): 1298-307. PMID 22576027
5. Sobhani I, Tap J, Roudot-Thoraval F, et al. Microbial dysbiosis in colorectal cancer (CRC) patients. PLoS One. Jan 27 2011; 6(1): e16393. PMID 21297998
6. Joossens M, Huys G, Cnockaert M, et al. Dysbiosis of the faecal microbiota in patients with Crohn's disease and their unaffected relatives. Gut. May 2011; 60(5): 631-7. PMID 21209126
7. Langhorst J, Elsenbruch S, Koelzer J, et al. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol. Jan 2008; 103(1): 162-9. PMID 17916108
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Date Comments 07/01/21 New policy, approved June 8, 2021. Fecal analysis in the diagnosis of intestinal dysbiosis and irritable
bowel syndrome is considered investigational.
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