Diet and counseling to see how meals affect gut health after CDI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes adults with non-recurrent CDI to receive meals plus different health counseling approaches over eight weeks. Meals are provided for two weeks, followed by similar meals for six more weeks, with counseling delivered by phone or video. Participants complete questionnaires and provide stool samples to track changes in the gut microbiome and potential recurrence risk. The study uses concealed diet assignments so the control group isn’t influenced by the specific diet during the trial, with full disclosure given after completion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.)

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Kira Newman, MD, PhD — University of Michigan
• Study coordinator: Kira Newman, MD, PhD
• Email: kinewman@med.umich.edu
• Phone: 734-615-4628

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.