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Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Primary Purpose

Recurrent Clostridium Difficile Infection, Fecal Microbiota Transplant

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MEND diet
mNICE diet
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Recurrent Clostridium Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MEND diet

mNICE (modified NICE) diet

Arm Description

patients being treated with FMT

patients being treated with FMT

Outcomes

Primary Outcome Measures

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.
Participant compliance with study procedures
24-hr dietary recalls will be used to assure adherence with the study diet

Secondary Outcome Measures

Bacterial diversity
Shannon diversity index
Bacterial diversity
Shannon diversity index
Bacterial diversity
Shannon diversity index
Similarity to donor bacterial composition
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Similarity to donor bacterial composition
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Similarity to donor bacterial composition
Using SourceTracker
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence

Full Information

First Posted
March 17, 2023
Last Updated
September 18, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05826418
Brief Title
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
Official Title
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Clostridium Difficile Infection, Fecal Microbiota Transplant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MEND diet
Arm Type
Experimental
Arm Description
patients being treated with FMT
Arm Title
mNICE (modified NICE) diet
Arm Type
Active Comparator
Arm Description
patients being treated with FMT
Intervention Type
Dietary Supplement
Intervention Name(s)
MEND diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
mNICE diet
Intervention Description
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 Outcome Measure Information:
Title
Participant acceptance of the diet
Description
Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.
Time Frame
4 weeks
Title
Participant compliance with study procedures
Description
24-hr dietary recalls will be used to assure adherence with the study diet
Time Frame
intervention to 4 weeks
Secondary Outcome Measure Information:
Title
Bacterial diversity
Description
Shannon diversity index
Time Frame
1 week
Title
Bacterial diversity
Description
Shannon diversity index
Time Frame
4 weeks
Title
Bacterial diversity
Description
Shannon diversity index
Time Frame
3 months
Title
Similarity to donor bacterial composition
Description
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Time Frame
1 week
Title
Similarity to donor bacterial composition
Description
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Time Frame
4 weeks
Title
Similarity to donor bacterial composition
Description
Using SourceTracker
Time Frame
3 months
Title
Bacterial composition
Description
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Time Frame
1 week
Title
Bacterial composition
Description
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Time Frame
4 weeks
Title
Bacterial composition
Description
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Khoruts, MD
Phone
612-625-8999
Email
khoru001@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Khoruts, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Khoruts, MD
Phone
612-625-8999
Email
khoru001@umn.edu

12. IPD Sharing Statement

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Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

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