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Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)

NCT07613645 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-29

No results posted yet for this 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.

Conditions

  • Clostridioides Difficile Infection

Interventions

OTHER

Diet (experimental diet)

Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.

OTHER

Health counseling sessions

Participant will have two health counseling visits with a member of the study team between weeks 2-8.

OTHER

Diet (control diet)

Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.

Sponsors & Collaborators

Principal Investigators

  • Kira Newman, MD, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613645 on ClinicalTrials.gov