Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Recurrent Clostridium Difficile Infection Clinical Trial

Official title:

Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826418
• Other study ID #: rCDI
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• Source: University of Minnesota
• Contact: Alexander Khoruts, MD
• Phone: 612-625-8999
• Email: khoru001[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Infections
• Fecal Microbiota Transplant
• Recurrent Clostridium Difficile Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Participant compliance with study procedures	24-hr dietary recalls will be used to assure adherence with the study diet	intervention to 4 weeks
Secondary	Bacterial diversity	Shannon diversity index	1 week
Secondary	Bacterial diversity	Shannon diversity index	4 weeks
Secondary	Bacterial diversity	Shannon diversity index	3 months
Secondary	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
Secondary	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
Secondary	Similarity to donor bacterial composition	Using SourceTracker	3 months
Secondary	Bacterial composition	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence	1 week
Secondary	Bacterial composition	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence	4 weeks
Secondary	Bacterial composition	Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence	3 months