Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Not Applicable

Recruiting

• Conditions: Recurrent Clostridium Difficile Infection; Fecal Microbiota Transplant
• Interventions: Dietary Supplement: mNICE diet; Dietary Supplement: MEND diet

• Registration Number: NCT05826418
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-24
• Study Start: 2023-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mNICE (modified NICE) diet	mNICE diet	patients being treated with FMT
MEND diet	MEND diet	patients being treated with FMT

Primary Outcome Measures

Name	Time	Method
Participant compliance with study procedures	intervention to 4 weeks	24-hr dietary recalls will be used to assure adherence with the study diet
Participant acceptance of the diet	4 weeks	Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.

Secondary Outcome Measures

Name	Time	Method
Bacterial composition	3 months	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Bacterial diversity	3 months	Shannon diversity index
Similarity to donor bacterial composition	3 months	Using SourceTracker

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States