Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)

ConditionClostridioides Difficile Infection

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Health counseling sessions
Diet (control diet)
Diet (experimental diet)

Treatment groups

20 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan

Lead sponsor

Michigan Nutrition Obesity Research Center

Collaborator

Source ClinicalTrials.gov