Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07613645
Status
Recruiting
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Conditions

  • Clostridioides Difficile Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Health counseling sessions — OTHER
    Participant will have two health counseling visits with a member of the study team between weeks 2-8.
  • Diet (control diet) — OTHER
    Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
  • Diet (experimental diet) — OTHER
    Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental Diet plus health counseling
    As stated earlier, the diet and intervention details will not be listed for concealment purposes.
  • Other: Diet (control diet per protocol) plus health counseling
    As stated earlier, the diet and intervention details will not be listed for concealment purposes.

Primary Outcome Measure

Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing [ Time Frame: Baseline, 2 weeks (post feeding period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Kira Newman, MD, PhD
[email protected]
734-615-4628
Kira Newman, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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