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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05826418
Other study ID # rCDI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date August 1, 2025

Study information

Verified date September 2023
Source University of Minnesota
Contact Alexander Khoruts, MD
Phone 612-625-8999
Email khoru001@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent - 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) - Ability to comply with study requirements - Age at least 18 years old Exclusion Criteria: - Underlying IBD - History of stomach surgery or bowel resection - Anticipated antibiotic exposure during the study period - Advanced liver disease - Ongoing alcohol or drug abuse - Pregnancy - Any reason felt by the investigator to complicate the feasibility of participation

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
MEND diet
Participants will be asked to adhere to their randomized MEND diet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet.
mNICE diet
Participants will be asked to adhere to their randomized mNICEdiet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant acceptance of the diet Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes. 4 weeks
Primary Participant compliance with study procedures 24-hr dietary recalls will be used to assure adherence with the study diet intervention to 4 weeks
Secondary Bacterial diversity Shannon diversity index 1 week
Secondary Bacterial diversity Shannon diversity index 4 weeks
Secondary Bacterial diversity Shannon diversity index 3 months
Secondary Similarity to donor bacterial composition Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure 1 week
Secondary Similarity to donor bacterial composition Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure 4 weeks
Secondary Similarity to donor bacterial composition Using SourceTracker 3 months
Secondary Bacterial composition Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence 1 week
Secondary Bacterial composition Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence 4 weeks
Secondary Bacterial composition Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence 3 months
See also
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Available NCT03786900 - Fecal Microbiota Transplantation (FMT): PRIM-DJ2727