Actively Recruiting
Diet for Prevention of Recurrent Clostridioides Difficile Infection
Led by University of Michigan · Updated on 2026-06-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
M
Michigan Nutrition Obesity Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how diet affects the gut microbiome in adults who have Clostridioides difficile infection (CDI). The study aims to understand how different health factors and diets might influence the risk of getting CDI again. Participants will be randomly assigned to receive meals and health counseling, with the study keeping the diet details hidden from participants during the trial to avoid bias. Participants will receive prepared meals for two weeks and will be asked to continue a similar diet for an additional six weeks. Health counseling sessions will be conducted by phone or online between weeks 2 and 8. The study includes two diet groups: an experimental diet and a control diet, both accompanied by health counseling. During the study, participants will complete questionnaires and provide multiple stool samples to assess changes in their gut microbiome. The primary outcome is the change in microbiome diversity after two weeks of feeding. Secondary outcomes include microbiome changes at eight weeks, incidence of recurrent CDI, quality of life related to CDI, and how well participants tolerate the diet. The study will run until June 2027.
CONDITIONS
Brief Title
Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and lifestyle considerations
- Availability for the duration of the study
- Non-recurrent non-fulminant CDI confirmed by laboratory, without CDI in prior 3 months or severe complications
- Currently receiving or planning to start standard CDI treatment with fidaxomicin or vancomycin
- No prior advanced therapy for C. difficile such as prolonged antibiotics, bezlotoxumab, fecal transplant, or microbial therapy
You will not qualify if you...
- Chemotherapy, immunotherapy, or transplant within the past 12 months
- Colon not in continuity (e.g., total colectomy or current ileostomy)
- Medical conditions requiring special fluid, sodium, or protein intake outside diet options
- Baseline diet with more than 11 grams fiber per 1000 kilocalories
- Diets that cannot be accommodated by the study kitchen such as low sodium, vegan, gluten-free, or Kosher
- Allergies or food restrictions that cannot be accommodated (lactose intolerance allowed)
- Unwillingness to stop probiotic supplements during the study
- Current antibiotic therapy continuing after CDI treatment
- Hospitalized or in skilled nursing facility at CDI treatment end
- Pregnancy or breastfeeding
- Inability to provide suitable stool samples for study analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive 2 weeks of prepared meals followed by 6 weeks of a similar diet.
Weekly visits for up to 8 weeks
Duration - Approximately 6 weeks
Participants have two health counseling visits with a member of the study team between weeks 2 and 8.
2 visits (in-person) between weeks 2 and 8
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
K
Kira Newman, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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