Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

University of Minnesota (UMN)

Status: Completed

Conditions: Fecal Microbiota Transplant; Recurrent Clostridium Difficile Infection

Treatments: Dietary Supplement: MEND diet; Dietary Supplement: mNICE diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05826418

rCDI

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

MEND diet

Experimental group

Description:

patients being treated with FMT

Treatment:

Dietary Supplement: MEND diet

mNICE (modified NICE) diet

Active Comparator group

Description:

patients being treated with FMT

Treatment:

Dietary Supplement: mNICE diet