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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
Clinical plans to undergo FMT therapy for treatment of rCDI (≥ 2 CDI recurrences following the initial episode within 1 year without contraindications to the treatment)
Age at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am planning to have FMT therapy for recurring C. diff infection.
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I am 18 years old or older.

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

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

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
1,377 Previous Clinical Trials
1,588,266 Total Patients Enrolled
Alexander Khoruts, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still open?

"Unfortunately, this medical trial is not presently recruiting. It was initially listed on May 1st 2023 and its information has been updated as of April 20th 2023. Fortunately, there are 44 other trials in a similar field that are currently enrolling patients."

Answered by AI
~17 spots leftby Aug 2025