Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

NCT04968951 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: GCO 18-1464
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors. Donors will be specifically screened for Fusobacterium and Sutterella species as well as for global diversity. It is unknown if treatment with antibiotics before FMT improves the engraftment and/or efficacy of FMT in UC, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before FMT therapy. The research team enroll patients from The Susan and Leonard Feinstein IBD Center and our established early diagnosis clinic at Mount Sinai Hospital (MSH).

Conditions

Ulcerative Colitis; FMT; Fecal Microbiota Transplant

Keywords

FMT; Fecal Microbiota Transplantation; Fecal Microbiota Transplant; Fecal Matter Transplant; Ulcerative colitis; UC

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with an adverse

  Safety as measured by proportion of participants with an adverse event through week 8

  8 Weeks

• Proportion of participants with a severe adverse

  Safety as measured by proportion of participants with a severe adverse event through week 8

  8 Weeks

Secondary Outcomes (9)

• Number of patients requiring escalation of medical therapies

  8 weeks

• Proportion of patients that achieve Mayo score 0 or 1

  8 weeks

• Number of patients with endoscopic remission

  8 weeks

• Change in Nancy score

  8 weeks

• Fecal calprotectin level

  baseline and 8 weeks

Study Arms (2)

FMT with Antibiotics

ACTIVE COMPARATOR

Participants will receive antibiotics before receiving Fecal Microbiota Transplantation

Drug: Metronidazole; Drug: Vancomycin; Biological: Fecal Microbiota Transplantation

FMT with placebo

PLACEBO COMPARATOR

Participants will receive placebo before receiving Fecal Microbiota Transplantation

Drug: Placebo; Biological: Fecal Microbiota Transplantation

Interventions

Metronidazole DRUG

Antibiotic treatment - 250 mg every 6 hrs for 5 days

Also known as: Flagyl

FMT with Antibiotics

Placebo DRUG

Placebo treatment

FMT with placebo

Vancomycin DRUG

Antibiotic treatment - 125 mg every 6 hrs for 5 days

FMT with Antibiotics

Fecal Microbiota Transplantation BIOLOGICAL

Encapsulated biologically active human fecal material (donor stool) is provided in capsule form. The fecal material is homogenized with sterile saline, then pelleted and re-suspended in sterile saline/40% glycerol. Participants will receive 15 FMT capsules per day for 3 consecutive days. Capsule are to be swallowed under direct supervision.

Also known as: FMT

FMT with Antibiotics; FMT with placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Adults aged 18 to 75 with UC, with initial diagnosis of UC \>3 months prior to time of study enrollment visit * Partial Mayo score of 4-10 with endoscopic subscore ≥2 on flexible sigmoidoscopy * Permissible UC medications include oral or rectal administered mesalamines * Corticosteroids must be discontinued at least 4 weeks before enrollment * Documented negative C. difficile and GI PCR for enteric pathogens (BioFire) testing before commencement of fecal microbiota transplantation * Previous documentation of ulcerative colitis based on colonoscopy/flexible sigmoidoscopy with compatible histology

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ari M Grinspan: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Metronidazole; Vancomycin; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Biological Therapy; Therapeutics

Study Officials

• Ari Grinspan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Antibiotics and placebo will be disguised
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Participants are assigned to one of two groups. One group will be assigned to receive pre-treatment with antibiotics before Fecal Microbiota Transportation. The other group will be assigned to receive pre-treatment without antibiotics (with placebo) before Fecal Microbiota Transplantation.

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: November 10, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)