Clinical Trial

Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)

Recruiting
View on ClinicalTrials.gov →
Summary
This study aims to evaluate the impact of diet on the gut microbiome in adults with Clostridioides difficile infection (CDI). Eligible participants will be randomized and receive meals plus different types of health counseling. Counseling visits will be by phone or online videoconference (e.g. Zoom). Meals will be provided for two weeks and then participants will be asked to continue similar meals for 6 more weeks. Participants will provide responses to questionnaires and multiple stool samples over the course of the study. The goal is to understand how different health factors might impact the risk of becoming infected again with C. difficile in the future. Of note, this study will conceal the intervention details (type of diets) so that the control group does not increase their intake with the particular diet during the study. Participants in the control arm will be unblinded at the end of the study during a debrief with a member of the study team. At that time participants will be informed of diet being tested.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2027-06 -> 2027-12 2026-07-09
minor Completion pushed: 2027-06 -> 2028-06 2026-07-09
critical Recruitment opened 2026-06-05
Trial Details
NCT Number NCT07613645
Lead Sponsor University of Michigan
Collaborators: Michigan Nutrition Obesity Research Center
Conditions Clostridioides Difficile Infection
Enrollment 20 participants
Start Date 2026-06-05
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-08