A new international consensus has been published in The Lancet Gastroenterology & Hepatology, setting standards for the development and use of microbiome testing in clinical practice. The consensus was reached by a multidisciplinary team of 69 experts from 18 countries, who used a Delphi process to agree on five key issues.
The first issue addresses general principles and minimum requirements for laboratories commercializing microbiome tests. These include adhering to high-quality standards, involving experts from different disciplines, and ensuring that customers are aware of the limited evidence supporting this testing. Patients should also have their treatment supervised by a referring healthcare professional after any changes are made based on the test results.
The consensus also emphasizes the importance of proper prescription, with licensed healthcare providers such as physicians, pharmacists, or dietitians making the decision. Self-prescription is discouraged, and patients should not suspend treatment or change their usual diet before testing.
For microbiome analysis, the report recommends using amplicon (e.g., 16S rRNA) or whole-genome sequencing, with ecological measures such as alpha and beta diversity measures and complete taxonomic profiling being used. However, conventional microbial cultures or polymerase chain reactions are not recommended for microbiome analysis.
The consensus also highlights the need for a standardized reporting of results, including patient medical history and test protocol, along with taxonomic profiles and dysbiosis indices. However, specific indices such as Firmicutes/Bacteroidetes ratio should be excluded from reports, as they do not capture the variation in the gut microbiome within the same host.
The report discourages post-testing therapeutic advice by the testing provider and instead emphasizes the responsibility of the referring healthcare professional who requested the testing. The panel also recommends that consumers or patients direct requests for microbiome testing be discouraged to avoid testing without a clear indication or awareness of limitations.
Despite the challenges in advancing the field, some companies are developing commercialized microbiome testing kits for healthy individuals, which can satisfy their curiosity about their fecal microbiome. However, these applications have less stringent regulatory needs and cannot include medical claims in the final report.
Overall, the new international consensus sets standards for microbiome testing in clinical practice, emphasizing the need for high-quality standards, proper prescription, and standardized reporting of results.
Source: https://www.gutmicrobiotaforhealth.com/new-international-consensus-on-microbiome-testing-in-clinical-practice