Condition: Clostridioides Difficile Infection · Sponsor: University of Michigan
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.
This description comes directly from the study's public registry record.
Kira Newman, MD, PhD · 734-615-4628 · kinewman@med.umich.edu
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| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07613645