Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

NCT02390726 | Unknown Early Phase 1 DMC

• 1 other identifier: 15373
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment. The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.

Conditions

Ulcerative Colitis, Active Moderate

Outcome Measures

Primary Outcomes (3)

• Asses Endoscopic Stages of the Colon Pre/Post FMT

  Assess endoscopic stage of the inflamed colon (endoscopic Mayo score) and assess the histologic stage of the biopsied colon (quiescent/mild/moderate/severe) pre and post FMT.

  2 years

• Asses Biologic Inflammatory Markers

  Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.

  2 years

• Review and Track Patient reported Outcomes via Validated Questionnaires

  Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36)

  2 Years

Secondary Outcomes (1)

• Change in metagenomic sequencing in Stool samples after FMT treatment

  After 6, 12, and 18 Weeks

Other Outcomes (1)

• Asses changes in T-cell measures and serotonin signaling in mucosal biopsy samples and peripheral blood samples

  2 years

Study Arms (2)

Control

SHAM COMPARATOR

Sham FMT and Sham Microbial Maintenance plus standard therapy

Biological: Placebo

Treatment

EXPERIMENTAL

FMT and microbial maintenance plus standard therapy

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

Treatment

Placebo BIOLOGICAL

Control

Eligibility Criteria

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

You may qualify if:

• Men or women 18-75 years of age.
• Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon
• Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response).
• Patients may be on any class of IBD-related medication (excluding steroids)
• Patients must be on stable medication regimen for at least 6 weeks prior to enrollment.
• Ability to understand and willingness to sign informed consent document

You may not qualify if:

• Patient who are asymptomatic
• Patients with severe, refractory disease (defined as Mayo scores of \> 10, or endoscopic disease activity score of \> 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol
• Prior colectomy
• Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture.
• Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
• Systemic antibiotic use within prior 6 weeks to enrollment
• Regular probiotic supplement use within prior 48 hours to enrollment
• Pregnancy or breastfeeding
• Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
• History of anaphylaxis (severe allergic reaction)
• Documented allergy to fluoroquinolones, metronidazole
• Life expectancy less than 12 months
• Age less than 18 or greater than 75 years of age
• History of esophageal or gastric motility disorders.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Crothers JW, Chu ND, Nguyen LTT, Phillips M, Collins C, Fortner K, Del Rio-Guerra R, Lavoie B, Callas P, Velez M, Cohn A, Elliott RJ, Wong WF, Vo E, Wilcox R, Smith M, Kassam Z, Budd R, Alm EJ, Mawe GM, Moses PL. Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. BMC Gastroenterol. 2021 Jul 8;21(1):281. doi: 10.1186/s12876-021-01856-9.

  PMID: 34238227 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Peter L Moses, MD

  The University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

US (1)