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Specialized Diets for Clostridium Difficile Infection

N/A
Recruiting
Led By Alexander Khoruts, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is researching a diet and gut microbiome to help people with recurrent Clostridioides difficle infection (rCDI) after fecal microbiota transplant (FMT). It is hoped that the diet can improve clinical outcomes.

Who is the study for?
This trial is for adults at least 18 years old who have had two or more recurrences of Clostridium difficile infection within a year and are planning to undergo fecal microbiota transplant (FMT) therapy. Participants must be able to follow the study requirements and give informed consent.
What is being tested?
The trial is testing two diets, MEND and mNICE, designed to optimize gut health after FMT in patients with recurrent C. difficile infections. The goal is to see how well these diets support recovery by nourishing the new microbiome established by FMT.
What are the potential side effects?
Since this trial involves dietary interventions, side effects may include gastrointestinal discomfort or changes in bowel habits as the body adjusts to new eating patterns aimed at enhancing gut microbiota.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant acceptance of the diet
Participant compliance with study procedures
Secondary study objectives
Bacterial composition
Bacterial diversity
Similarity to donor bacterial composition

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MEND dietExperimental Treatment1 Intervention
patients being treated with FMT
Group II: mNICE (modified NICE) dietActive Control1 Intervention
patients being treated with FMT

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,928 Total Patients Enrolled
Alexander Khoruts, MDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
47 Total Patients Enrolled
~8 spots leftby Aug 2025
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