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Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05067595
Collaborator
(none)
32
Enrollment
1
Location
4
Arms
30
Anticipated Duration (Days)
32.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Colonoscopy
  • Biological: Fecal Microbiota Transplantation
  • Biological: Fecal Microbiota Transplantation
  • Dietary Supplement: Nutritional Supplementation
  • Other: Survey Administration
 Phase 1

Detailed Description

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO daily on days 1-42.

ARM II: Patients undergo lower FMT via colonoscopy on day 0.

ARM III: Patients receive upper FMT capsules PO over 2 days. Patients also receive fiber supplementation PO daily on days 0-41.

ARM IV: Patients receive upper FMT capsules PO over 2 days.

After completion of study treatment, patients are followed up for 180 days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled, Phase I Study of Fecal Microbiota Transplant and Dietary Fiber Supplementation in Graft Versus Host Disease
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (lower FMT, fiber supplementation)

Patients undergo lower FMT via colonoscopy on day 0, and receive upper FMT capsules PO over 2 days. Patients also receive fiber supplementation PO daily on days 1-42.

Procedure: Colonoscopy
Undergo lower FMT via colonoscopy

Biological: Fecal Microbiota Transplantation
Given upper FMT PO
Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant

    • Biological: Fecal Microbiota Transplantation
    Undergo lower FMT via colonoscopy
    Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant

    • Dietary Supplement: Nutritional Supplementation
    Given dietary fiber supplementation PO
    Other Names:
  • Supplementation

    • Other: Survey Administration
    Ancillary studies
    Experimental: Arm II (lower FMT)

    Patients undergo lower FMT via colonoscopy on day 0, and receive upper FMT capsules PO over 2 days.

    Procedure: Colonoscopy
    Undergo lower FMT via colonoscopy

    Biological: Fecal Microbiota Transplantation
    Given upper FMT PO
    Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant

    • Biological: Fecal Microbiota Transplantation
    Undergo lower FMT via colonoscopy
    Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant

    • Other: Survey Administration
    Ancillary studies
    Experimental: Arm III (upper FMT, fiber supplementation)

    Patients receive upper FMT capsules PO over 2 days. Patients also receive fiber supplementation PO daily on days 0-41.

    Biological: Fecal Microbiota Transplantation
    Given upper FMT PO
    Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant

    • Dietary Supplement: Nutritional Supplementation
    Given dietary fiber supplementation PO
    Other Names:
  • Supplementation

    • Other: Survey Administration
    Ancillary studies
    Experimental: Arm IV (upper FMT)

    Patients receive upper FMT capsules PO over 2 days.

    Biological: Fecal Microbiota Transplantation
    Given upper FMT PO
    Other Names:
  • Fecal Material Transplantation
  • Fecal Transplantation
  • FMT
  • Poo Transplant
  • Poop Transplant
  • Stool Transplant

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Bacterial composition of stool [At baseline]

      Analyses will consist of summary statistics of the bacterial diversity in the microbiome (e.g., the alpha diversity, the abundance of bacterial species associated with protection from graft versus host disease [GvHD]).

    2. Bacterial composition of stool [At day 28 after fecal microbiota transplant]

      Analyses will consist of summary statistics of the bacterial diversity in the microbiome (e.g., the alpha diversity, the abundance of bacterial species associated with protection from graft versus host disease [GvHD]).

    3. Bacterial genes in stool [At baseline]

      Specifically abundance of genes related to fiber fermentation and short chain fatty acids (SCFA) production metabolites in stool, specifically short chain fatty acids will be assessed.

    4. Bacterial genes in stool [At day 28 after fecal microbiota transplant]

      Specifically abundance of genes related to fiber fermentation and short chain fatty acids (SCFA) production metabolites in stool, specifically short chain fatty acids will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • History of allogeneic hemopoietic stem cell transplant in the past 100 days

    • Post-engraftment, defined by three consecutive days of sustained neutrophil engraftment with an absolute neutrophil count of at least 500 cells/mm^3

    • Moderate to severe acute GI GvHD stage 2 or higher as measured by the modified Glucksberg criteria and averaged over 3 consecutive days. In patients who have already had GI biopsy, biopsy histology must be compatible with GVHD, although biopsy is not required

    Exclusion Criteria:

    • History of previous serious adverse events associated with FMT

    • History of bowel perforation

    • History of bowel resection

    • History of intestinal obstruction

    • History of gastric bypass

    • History of diverticulitis

    • History of inflammatory bowel disease (i.e. Crohn's disease and ulcerative colitis)

    • History of celiac disease confirmed by serologic testing or small bowel biopsy

    • History of severe dietary allergy as designated by World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System grade 2 or more

    • Current evidence of mechanical obstruction of the bowel

    • Known allergies to sodium chloride, glycerol, theobroma oil, hide bovine gelatin, sodium lauryl sulfate, colorants FD&C, or titanium dioxide

    • Currently pregnant, planning to become pregnant or breastfeeding during the study period. Women of childbearing potential (those who are not post-menopausal or post-hysterectomy) must be negative for pregnancy per urine pregnancy test at enrollment

    • Individuals with the ability to conceive children who are not willing to abstain from sexual activity or use an effective form of birth control during the duration of the study

    • Unwilling or unable to participate in study procedures including oral intake of FMT, colonoscopy, fiber supplementation, collection of stool samples and completion study surveys

    • Cannot reasonably and safely participate in the study in the opinion of the investigators

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center

    Investigators

    • Principal Investigator: David Fredricks, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05067595
    Other Study ID Numbers:
    • RG1006202
    • NCI-2019-07698
    • 10276
    First Posted:
    Oct 5, 2021
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Jun 2, 2022