Clinical trial NCT05826418: Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
Official title: Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Clostridium Difficile Infection
Fecal Microbiota Transplant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant acceptance of the diet
timeFrame: 4 weeks
measure: Participant compliance with study procedures
timeFrame: intervention to 4 weeks
Secondary outcomes:
measure: Bacterial diversity
timeFrame: 1 week
measure: Bacterial diversity
timeFrame: 4 weeks
measure: Bacterial diversity
timeFrame: 3 months
measure: Similarity to donor bacterial composition
timeFrame: 1 week
measure: Similarity to donor bacterial composition
timeFrame: 4 weeks
measure: Similarity to donor bacterial composition
timeFrame: 3 months
measure: Bacterial composition
timeFrame: 1 week
measure: Bacterial composition
timeFrame: 4 weeks
measure: Bacterial composition
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alexander Khoruts, MD
role: PRINCIPAL_INVESTIGATOR
References: