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Guided Protocol for Fecal Microbial Characterization by 16S rRNA-Amplicon Sequencing

Guided Protocol for Fecal Microbial Characterization by 16S rRNA-Amplicon Sequencing

Published on: March 19, 2018

International consensus statement on microbiome testing in clinical practice.

Serena Porcari¹, Benjamin H Mullish², Francesco Asnicar³

¹Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

The Lancet. Gastroenterology & Hepatology

|December 8, 2024

Summary

This summary is machine-generated.

The gut microbiome shows diagnostic potential, but clinical evidence is lacking. Experts recommend standardized practices for reliable human microbiome testing to ensure clinical value and prevent resource waste.

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Area of Science:

Microbiome research
Clinical diagnostics
Medical technology assessment

Background:

Growing interest in the gut microbiome for medical diagnostics.
Limited clinical evidence for microbiome testing's usefulness.
Unregulated direct-to-consumer microbiome tests pose risks of resource waste and clinical mismanagement.

Purpose of the Study:

To standardize best practices for clinical implementation of microbiome testing.
To establish a regulatory framework for microbiome diagnostics.
To minimize inappropriate test use and promote evidence-based development.

Main Methods:

Convened an international multidisciplinary expert panel.
Developed recommendations on principles, requirements, indications, pre-testing, analysis, reporting, and clinical value.
Evaluated current knowledge gaps and future research directions.

Main Results:

Established standardized best practices for microbiome testing.
Provided a framework for regulating microbiome diagnostic tests.
Identified key areas for future research and development.

Conclusions:

Standardized microbiome testing is crucial for clinical implementation.
A regulatory framework is needed to ensure the validity and utility of microbiome diagnostics.
Evidence-based development will optimize the use of human microbiome diagnostics in medicine.