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NCT Number: NCT07613645

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). 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.

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Key information

Conditions

Clostridioides Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Kira Newman, MD, PhD

CONTACT

[email protected]

734-615-4628

Kira Newman, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Health counseling sessions

Other

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

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 (experimental diet)

Other

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

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: baseline to week 8

    Measured by Shannon Index via 16S rRNA.

  2. Incidence of recurrent CDI

    Time frame: baseline to week 8

    Laboratory-confirmed symptomatic infection requiring treatment.

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

    Time frame: Baseline to Week 8

    Patient-reported health-related quality of life assessed using the Clostridioides difficile Quality of Life Survey (Cdiff32) total score (range 0-100; higher scores indicate better quality of life).

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

    Time frame: 2 weeks (during the provided meal period)

    This is during the 2-weeks of receiving provided meals.

Study contacts

Contact information is provided by the study sponsor or research team.

Kira Newman, MD, PhD

CONTACT

[email protected]

734-615-4628

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Michigan Nutrition Obesity Research Center

Registry information

Official study title

Diet for Prevention of Recurrent C. Difficile Infection

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 29, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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