FDA NewsPerspective

FDA issues safety alert for FMT

March 13, 2020
Two patients died and four were hospitalized after receiving fecal microbiota transplantations from OpenBiome stool donors, according to a safety…
In the Journals

Rise in gut microbial metabolite may elevate CHD risk

February 17, 2020
Healthy women with long-term changes in plasma trimethylamine N-oxide, a choline metabolite produced from gut microbiota, had an increased risk for…

Rebiotix completes enrollment for phase 3 trial of C. diff microbiota therapy

February 14, 2020
Investigators have completed enrollment in a phase 3 trial set to investigate RBX2660, a therapy that uses the gut microbiota to treat…
In the Journals

‘It pays’ to check the gut microbiome in patients with cirrhosis

February 11, 2020
Gut microbiota analysis was cost-effective for predicting and possibly preventing 90-day readmissions for cirrhosis, according to study results. …
In the Journals

Unhealthy gut microbiome may be hallmark of PCOS among teens

January 24, 2020
Adolescents with obesity and polycystic ovary syndrome have an altered gut microbiome compared with girls without PCOS with a similar BMI and dietary…
In the Journals

Dysbiosis from H. pylori infection may be involved in gastric carcinogenesis

January 2, 2020
Microbial dysbiosis caused by Helicobacter pylori infection may be an important driver in the development of gastric cancer, according to study…
In the Journals

7 recent reports on the gut microbiome

December 5, 2019
Healio Gastroenterology and Liver Disease presents the following reports on the most recent research and news on the gut microbiome. These reports…
In the Journals

Lactulose breath test predicts Xifaxan response in IBS-D

December 5, 2019
Patients with diarrhea-predominant irritable bowel syndrome who had a positive baseline result from a lactulose breath test were more likely to…
In the Journals

Guest commentary: FMT, ‘a life-saving therapy,’ needs physician, industry cooperation

November 6, 2019
In this guest commentary, Jessica Allegretti , MD, MPH, of the Brigham and Women’s Hospital Crohn’s and Colitis
FDA NewsPerspective

FDA hears testimony on enforcement discretion of FMT for C. diff

November 4, 2019
The FDA held a public comment session on Monday in Washington, D.C., to hear testimony on the agency’s policy on enforcement discretion of…