Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis or Clearance of ARO

NCT03834051 | Terminated Results

• 1 other identifier: GID.FMT
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the efficacy of FMTs via rectal administration for 1) symptom improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory bowel disease or irritable bowel syndrome; 2) clearance of antimicrobial resistant organism from the gastrointestinal tract.

Conditions

Dysbiosis; Antimicrobial Resistant Organism

Outcome Measures

Primary Outcomes (5)

• Efficacy of FMT in Active Ulcerative Colitis

  Evaluate the Ulcerative Colitis Disease Activity Index from baseline 4 weeks, 12 weeks and 1 year following FMT using partial-MAYO score. Partial-MAYO is a validated scoring system to determine the activity of UC. it uses three non-invasive components (stool frequency, rectal bleeding and physician's global assessment. Each of the 3 clinical parameters is assigned a score from 0 to 3 according to the clinical evaluation with a total possible score of 9. Higher the score, more severe the disease; score of 0 - 1 is considered in remission; 2 - 4 mild; 5 - 7 moderate; \> 7 severe colitis.

  1 year

• Efficacy of FMT for Irritable Bowel Syndrome

  IBS severity symptom severity score scale (IBS-SSS) from baseline compared to following FMT in participants with irritable bowel syndrome. IBS-SSS is a validated instrument with a scoring system which produces a meaningful value that is both reproducible and sensitive to change. The instrument contains five questions across the following domains: pain; distension; bowel score and quality of life. Each question can generate a score from 0 to 100 using prompted visual analogue scales; the total scores can range from 0 to 500 with a maximum total score of 500. IBS-SSS is mild for scores 75 - 175; moderate 176 - 300 and severe if \> 300.

  1 year

• Efficacy of FMT in Crohn's Disease

  The Crohn's Disease Activity Index (CDAI) was measured at baseline and following FMT. CDAI is a validated instrument used in adults with active Crohn's disease. The index consists of eight factors, 2 of which are subjective: stool habits; pain; general well being; features of extra intestinal disease; use of opiates for diarrhea; abdominal mass; hematocrit (hct); and percentage of body weight below standard. Scores range from 0 to \~ 600: \> 450 is severe disease; 220 - 450 moderately active disease; 150 - 219 mildly active disease. Clinical remission is defined as a CDAI score \<150, clinical response is either a CDAI score \<150 or a CDAI reduction of ≥100 from baseline.

  4 weeks

• Efficacy of FMT in Microscopic Colitis (MC) Based on Physician's Global Assessment

  Physician's global assessment and number of unformed bowel movements per 24 hours were employed at baseline and following FMT to assess response to FMT as these parameters used to determine MC treatment in clinical trials and care. For physician's global assessment, lower the score, lesser the disease activity: 0 = no disease activity; 1 = mild activity; 2 = moderate activity; 3 = severe disease activity

  Baseline to 4 weeks following FMT

• Efficacy of FMT in Microscopic Colitis (MC) Based on Number of Unformed Bowel Movements in 24 Hours

  Physician's global assessment and number of unformed bowel movements per 24 hours were employed at baseline and following FMT to assess response to FMT as these parameters used to determine MC treatment in clinical trials and care.

  Baseline to 4 weeks following FMT

Study Arms (1)

Open Label

EXPERIMENTAL

Fecal Microbiota Transplantation

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Fecal Microbiota Transplantation Rectal Administration Open Label

Open Label

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Able to provide informed consent.
• Willing and able to comply with all the required study procedures.
• Rectally colonized with antimicrobial resistant organisms: Extended-spectrum of beta-lactamase, Carbapenem resistant, vancomycin resistant enterococci

You may not qualify if:

• Planned or actively taking another investigational product
• Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L
• Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
• Peripheral white blood cell count \> 30.0 x 109/L AND temperature \> 38.0 ºC
• Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
• Unable to tolerate FMT or enema for any reason.
• Requiring systemic antibiotic therapy at the time of FMT.
• Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed
• Severe underlying disease such that the patient is not expected to survive for at least 30 days.
• History of severe allergy to any food

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

MeSH Terms

Conditions

Dysbiosis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Limitations and Caveats

No Individuals with antibiotic resistant organism colonization or pouchitis were enrolled into the study. In addition, patient-reported Health-Related Quality of Life outcomes via validated questionnaire, RAND were not completed by the participants.

Results Point of Contact

• Title: Dr. Christine Lee
• Organization: Vancouver Island Health Authority

christine.lee@viha.ca

250 519 1898

Study Officials

• Christine Lee

  Vancouver Island Health Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: February 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 8, 2020
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)