Restoring the Gut Microbiome in C. Diff Patients Reduces Anxiety | IDWeek 2023

Restoring a healthy microbiome in patients with recurrent Clostridioides difficile (C. diff) infection (CDI) was associated with improving patients’ health-related quality of life (HRQL). These are the findings of a poster presented at ID Week being held this week in Boston.

The human microbiome is a complex community of microorganisms in and on the body. In the gut, an imbalance of the microbiome can lead to C. diff, a serious disease that causes severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis. It has been estimated that up to 35% of cases recur after initial diagnosis.

Recurrent C. diff infections have been shown to impact quality of life, and a previous study published in 2022 found that anxiety levels are different in patients with initial C. diff infections compared with patients who have recurrent infections.

Researchers in the current study were led Paul Feuerstadt, M.D., assistant clinical professor of Medicine, Yale University School of Medicine and PACT-Gastroenterology Center in Westport, Conn. They aimed to assess the association between individual gut microbiome and the health-related quality of life of patients with recurrent infections.

Paul Feuerstadt, M.D.

They found that a healthier microbiome was associated with improved quality-of-life scores. “The findings in our study at IDWeek start to give us deeper insights into the impact of the microbiota on health-related quality of life in patients with recurrent C. difficile who are being treated,” Feuerstadt told MHE by email. “We see that the classes of Bacteroidia and Clostridia both are beneficial to preventing a recurrence of this devastating infection but also are helpful to patients’ physical, mental and social status.”

Researchers conducted a post-hoc analysis of patients enrolled in the PUNCH CD3, which is a phase 3 study of patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy. Patients were given Ferring Pharmaceutical’s Rebyota, a fecal microbiota transplantation therapy that was developed by Rebiotix, a Ferring company.

Rebyota is indicated for the prevention of recurrent C. diff and is administered rectally as a single dose and is prepared from stool donated by qualified individuals. The donors and the donated stool are tested for a panel of transmissible pathogens. Rebyota was approved in December 2022 as the first fecal microbiota product for the prevention of recurrence of CDI in people 18 years of age and older.

A total of 176 (out of 262) patients were assessed in this study. HRQL was measured using the Clostridioides difficile Health-related Quality-of-Life Questionnaire (Cdiff32) with a total score, as well as scores for physical, mental, and social. Researchers also measured levels of several bacteria, including the beneficial gut microbiota (Bacteroidia and Clostridia) versus other bacteria (Gammaproteobacteria and Bacilli).

“From the PUNCHCD3 trial, as one might expect, the patients that did not recur had an improvement in HRQOL, but that effect was larger in those who received Rebyota versus those that received placebo,” Feuerstadt said. “Most interestingly, in those that received Rebyota who did recur, they showed absolute increases in their HRQOL whereas those that received placebo who recurred, stayed flat on the HRQOL measurements. It was this finding that spurred our interest to tease out the changes in the microbiota that might impact HRQOL, resulting in the study you see at IDWeek in 2023.”

Investigators suggested that additional research could help address the underlying pathways of how changes in the gut microbiome influences quality-of-life scores.