Skip to main content
OpenTrials
Completed

NCT Number: NCT05826418

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Participant acceptance of the diet

    Time frame: 4 weeks

    Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.

  2. Participant compliance with study procedures

    Time frame: intervention to 4 weeks

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

Secondary outcomes

  1. Bacterial diversity

    Time frame: 1 week

    Shannon diversity index

  2. Bacterial diversity

    Time frame: 4 weeks

    Shannon diversity index

  3. Bacterial diversity

    Time frame: 3 months

    Shannon diversity index

  4. Similarity to donor bacterial composition

    Time frame: 1 week

    Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure

  5. Similarity to donor bacterial composition

    Time frame: 4 weeks

    Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure

  6. Similarity to donor bacterial composition

    Time frame: 3 months

    Using SourceTracker

  7. Bacterial composition

    Time frame: 1 week

    Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence

  8. Bacterial composition

    Time frame: 4 weeks

    Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence

  9. Bacterial composition

    Time frame: 3 months

    Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.