Panel Offers Best Practice Statement for Microbiota Testing

TOPLINE: 

Microbiota analysis is not ready for use in clinical practice to diagnose disease or guide treatment, a new expert consensus statement concluded.

METHODOLOGY:

• An international multidisciplinary panel of experts was convened to establish a framework to regulate the provision of microbiome testing, minimize the use of inappropriate tests, and pave the way for the evidence-based development and use of human microbiome diagnostics in clinical medicine.
• The panel produced a consensus statement following a multistep process that included identifying key issues and building corresponding working groups.

TAKEAWAY:

• Five working groups provided 35 statements covering general principles and minimum requirements for providing microbiome testing, procedural steps before testing, appropriate methods for conducting microbiome analyses, characteristics of microbiome reports, and the relevance of microbiome testing in clinical practice now and in the future.
• The panel identified criteria and standards to adhere to when providing microbiome testing, but they pointed out that there is little evidence for the use of such diagnostics in clinical practice.
• The panel provided recommendations on the use, management, and protection of data generated by microbiome testing.

IN PRACTICE:

“[T]here is still no consolidated and direct evidence that microbiome-based diagnostics benefit the clinical management of gastrointestinal or extraintestinal disorders, either via an increase of clinical efficacy nor in a reduction of side-effects,” the authors wrote.

SOURCE: 

The consensus paper, led by panel coordinator Gianluca Ianiro, Università Cattolica del Sacro Cuore, Rome, Italy, was published online in The Lancet Gastroenterology & Hepatology.

LIMITATIONS:

Low-income and middle-income countries were not represented on the panel, which could limit broad implementation of the recommendations. Statements were presented as expert opinions, and an approach aimed at evaluating the quality of evidence and the strength of recommendations could not be applied. Owing to the advancement of technologies and the increase in pertinent evidence, the recommendations might become outdated quickly. The panel concluded that their consensus statement would have little use if further studies do not evaluate the value of microbiome testing in human disorders.

DISCLOSURES:

No specific funding for the consensus report was declared, but several experts were supported by institutional and/or Italian government grants. Ianiro has received personal fees for acting as speaker for Biocodex, Danone, Sofar, Malesci, Metagenics, Illumina, and Tillotts Pharma, and for acting as consultant or advisor for Ferring Therapeutics, Giuliani, Metagenics, and Tillotts Pharma. Many, but not all, of the coauthors have relationships with industry.