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Gut Microbiome

The gut microbiome is one of the most promising areas of science today. Researchers are currently investigating how to manipulate the gut microbiome to treat disease and improve human health.

FDA approves first FMT therapy and issues guidance

On Nov. 30, 2022, FDA approved the first fecal microbiota therapy (FMT) for recurrent Clostridioides difficile infection (CDI). This approval came days after FDA issued guidance on regulatory requirements for stool banks providing FMT products. Read on for a summary of the new regulations and what they mean for GIs and patients with recurrent CDI.

AGA clinical guideline: The role of probiotics in the management of gastrointestinal disorders

This AGA guideline finds that evidence to support use of probiotics to treat digestive diseases is greatly lacking, identifying only three clinical scenarios where current data suggests that probiotics may benefit patients.

AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of Clostridioides difficile (C. difficile) infection in 90 percent of patients across 20 North American FMT practice sites. 

Microbiome news, resources & education

Microbiome Minute

Welcome to a new series where experts break down the most interesting research developments in the space with 1-minute summaries.

Nutrition and probiotics

These resources address our current understanding of the interplay between nutrition and the gut microbiome, and what it all may mean for human health and disease.

After conducting a detailed review of available literature, AGA released clinical guidelines finding that for most digestive conditions there is not enough evidence to support the use of probiotics. 

The AGA Center for Gut Microbiome Research and Education responds to new probiotics research. 

Share these resources with your patients to help them understand probiotics: what they do, who they are right for, how to choose them and safety information. 

Fecal Microbiota Transplantation

Fecal microbiota transplantation (FMT) is the proof-of-concept for all microbiome-targeting therapies currently in development. These resources cover the current state of evidence for FMT and provide guidance on how to incorporate FMT into your practice. 

On Nov. 30, 2022, FDA approved the first fecal microbiota therapy for recurrent CDI, Rebyota®. FDA also issued new requirements for stool banks and health care professionals using FMT material. 

Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90 percent of patients across 20 North American FMT practice sites. Few serious side effects were reported. 

In CGH, Dr. Colleen R. Kelly and colleagues provide guidance to researchers on the preparation and submission of investigational new drug (IND) applications to study FMT. 

In Gastroenterology, Dr. Colleen R. Kelly and colleagues discuss indications, methodologies, mechanisms and outlook on fecal microbiota transplantation (FMT). 

Share this webpage with your patients to help them understand FMT as a treatment option for recurring C. difficileinfection. 

Follow these guidelines to properly code and bill private payors and Medicare for fecal microbiota transplant (FMT). 

 

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AGA Center for Gut Microbiome Research & Education
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