Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Clostridium Difficile Infection; Fecal Microbiota Transplant
• Intervention / Treatment: Dietary supplement: MEND diet; Dietary supplement: mNICE diet

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Khoruts, MD; Phone Number: 612-625-8999; Email: khoru001@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Alexander Khoruts, MD; Phone Number: 612-625-8999; Email: khoru001@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEND diet; patients being treated with FMT	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.
Active Comparator: mNICE (modified NICE) diet; patients being treated with FMT	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial diversity	Shannon diversity index	1 week
Bacterial diversity	Shannon diversity index	4 weeks
Bacterial diversity	Shannon diversity index	3 months
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
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
Similarity to donor bacterial composition	Using SourceTracker	3 months
Bacterial composition	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence	1 week
Bacterial composition	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence	4 weeks
Bacterial composition	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence	3 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Alexander Khoruts, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: rCDI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No