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NCT07613645 · ClinicalTrials.gov registry record · NA
Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)
A NA study, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT07613645: Recruiting NA study, sponsored by University of Michigan.
NCT07613645 is a NA study that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07613645, a NA study, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline to week 2 (post feeding period) in alpha-diversity of fecal microbiome by 16S rRNA sequencing using Shannon index.
Interventions
- OTHER Health counseling sessions
- OTHER Diet (control diet)
- OTHER Diet (experimental diet)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-06-05 |
| Est. Completion | 2028-06 |
| Phase | NA |
What NCT07613645 shows while recruiting
NCT07613645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Health counseling sessions is the first listed.
NCT07613645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07613645 about?
NCT07613645 is a clinical study titled "Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)". 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)...
What is the current status of trial NCT07613645?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-06-05. Estimated completion is 2028-06.
What interventions are being tested in trial NCT07613645?
The interventions under investigation include: Health counseling sessions (OTHER), Diet (control diet) (OTHER), Diet (experimental diet) (OTHER).
Who is sponsoring clinical trial NCT07613645?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07613645's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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