Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

NCT05826418 | Completed

• 1 other identifier: rCDI
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Clostridium Difficile Infection; Fecal Microbiota Transplant

Outcome Measures

Primary Outcomes (2)

• 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

• Participant compliance with study procedures

  24-hr dietary recalls will be used to assure adherence with the study diet

  intervention to 4 weeks

Secondary Outcomes (9)

• Bacterial diversity

  1 week

• Bacterial diversity

  4 weeks

• Bacterial diversity

  3 months

• Similarity to donor bacterial composition

  1 week

• Similarity to donor bacterial composition

  4 weeks

Study Arms (2)

MEND diet

EXPERIMENTAL

patients being treated with FMT

Dietary Supplement: MEND diet

mNICE (modified NICE) diet

ACTIVE COMPARATOR

patients being treated with FMT

Dietary Supplement: mNICE diet

Interventions

MEND diet DIETARY_SUPPLEMENT

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.

MEND diet

mNICE diet DIETARY_SUPPLEMENT

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.

mNICE (modified NICE) diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Alexander Khoruts, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)