NCT07613645

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

May 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

May 21, 2026

Last Update Submit

July 6, 2026

Conditions

Clostridioides Difficile Infection

Keywords

DietHealth counselingSurveysStool samples

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing

    Change from baseline to week 2 (post feeding period) in alpha-diversity of fecal microbiome by 16S rRNA sequencing using Shannon index.

    Baseline, 2 weeks (post feeding period)

Secondary Outcomes (4)

  • Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA)

    baseline to week 8

  • Incidence of recurrent CDI

    baseline to week 8

  • Change in CDI-related Quality of Life (QOL) baseline to Week 8

    Baseline to Week 8

  • Tolerability of diet based on the mean percent of meals consumed during the first 2 weeks

    2 weeks (during the provided meal period)

Study Arms (2)

Experimental Diet plus health counseling

EXPERIMENTAL

As stated earlier, the diet and intervention details will not be listed for concealment purposes.

Other: Diet (experimental diet)

Diet (control diet per protocol) plus health counseling

OTHER

As stated earlier, the diet and intervention details will not be listed for concealment purposes.

Other: Health counseling sessionsOther: Diet (control diet)

Interventions

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 (control diet per protocol) plus health counseling
Health counseling sessionsOTHER

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

Diet (control diet per protocol) plus health counseling
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.

Experimental Diet plus health counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock, hypotension, ileus, or megacolon)
  • Currently receiving treatment or with plan to initiate treatment for CDI
  • CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x 10-14 days)
  • No prior advanced therapy for C. difficile (i.e. prolonged antibiotic therapy, bezlotoxumab, fecal transplant, other microbial therapy)

You may not qualify if:

  • Chemotherapy, immunotherapy, or transplant within 12 months
  • Colon not in continuity (i.e. status post total colectomy or with current ileostomy)
  • Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options
  • Baseline diet with \> 11grams fiber/1000 kilocalories
  • Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen
  • Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact eligibility)
  • Unwilling to stop probiotic supplements during the study period
  • Current antibiotic therapy that will continue after CDI treatment has finished
  • Hospitalized or in skilled nursing facility at time of CDI treatment conclusion
  • Pregnancy or breast-feeding
  • Unable to provide a stool sample of appropriate quality for further analysis (i.e. low volume, adulterated, delayed return, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Diet

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kira Newman, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kira Newman, MD, PhD

CONTACT

734-615-4628kinewman@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The type of diet will be masked to the health counseling group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to one of the two groups and will be stratified by CDI therapy (vancomycin vs. fidaxomicin) to ensure balance between both arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 29, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)