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Diet and Recurrent Clostridioides Difficile Infection (CDI) Study

This study is looking at how different diets affect the gut microbiome (the collection of bacteria in your intestines) in adults who have had a Clostridioides difficile infection (CDI). If you join, you'll be randomly assigned to receive either a 'control diet' or an 'experimental diet'. For the first two weeks, all your meals will be provided, and then you'll be asked to follow a similar diet for six more weeks. You'll also have two health counseling sessions by phone or video call. Researchers will collect questionnaires and stool samples to understand if diet can help prevent future C. difficile infections. The study plans to enroll 20 participants and is currently unclear on its recruitment status.

Study design
This is an interventional study that will randomly assign 20 participants to receive either a control diet or an experimental diet, along with health counseling.
What's involved
You will have two health counseling visits, receive prepared meals for two weeks, and then follow a similar diet for six more weeks. You will also provide responses to questionnaires and multiple stool samples.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 2 weeks (post feeding period), but participants are asked to follow a diet for 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07613645

Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)

Recruiting
NAAges 18+InterventionalPrevention
University of Michigan
~20 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Health counseling sessionsDiet (control diet)Diet (experimental diet)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing
Measured over Baseline, 2 weeks (post feeding period)

Conditions

Clostridioides Difficile Infection

Explore related trials

Clostridium difficile Infection

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Kira Newman, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Kira Newman, MD, PhD
[email protected]
734-615-4628
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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.)

What this trial measures

  • Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencingBaseline, 2 weeks (post feeding period)

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