Multidisciplinary Delphi consensus statement on minimal standards for clinical metadata and end points in microbiome...

Area of Science:

• Microbiome Research
• Clinical Studies
• Bioinformatics

Background:

• Microbiome research, particularly gut microbiome studies, has advanced significantly over the past decade.
• A critical gap exists in harmonizing methodologies for microbiome-based clinical studies.
• Key areas lacking standardization include metadata, reference materials, sampling, data analysis, and clinical endpoints.

Purpose of the Study:

• To address the lack of standardization in gut microbiome clinical studies.
• To develop consensus-based recommendations for harmonizing microbiome research protocols.
• To promote coherence and consistency in microbiome clinical research and data reporting.

Main Methods:

• A two-round Delphi survey was conducted within the Horizon Europe Human Microbiome Action (HMA) consortium.
• The survey involved 72 experts globally in the first round and 61 in the second, with an 85% retention rate.
• The survey focused on standardizing metadata collection, sampling, data generation/sharing, and standard operating procedures.

Main Results:

• The Delphi survey successfully gathered expert consensus on key aspects of microbiome clinical studies.
• Fifteen comprehensive recommendations were generated by the HMA consortium based on the survey outcomes.
• The recommendations provide a framework for standardizing gut microbiome research, focusing on gastrointestinal and gut-organ axis diseases.

Conclusions:

• Standardization of microbiome clinical studies is essential for reliable and reproducible research.
• The HMA consortium's 15 recommendations offer a pathway to harmonize gut microbiome research practices.
• Adoption of these recommendations by the research community will enhance the quality and comparability of microbiome data.