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Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03006809
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Najwa Elnachef, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 21, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE March 2, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • The occurrence of a Serious Adverse event (SAE), solicited and unsolicited AE, new gastrointestinal medical condition and diagnoses from FMT treatment or new infection from FMT treatment [ Time Frame: up to 1 year ]
    safety endpoint
  • Steroid-free Clinical Remission at week 9 + endoscopic remission or response defined as total Mayo score ≤ 2 with all four sub-scores ≤ 1 and a ≥ 1 point reduction in endoscopy sub-score [ Time Frame: 8 weeks post initial treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • Changes in microbiome with FMT therapy. Changes in the microbiome: assessed by frequent stool sampling for 16S rRNA analysis prior to each FMT therapy and after the last capsule/enema dose [ Time Frame: up to 1 year ]
  • Clinical Response: decrease in Mayo score by ≥ 3 points, decrease in bleeding subscore by ≥ 1, or absolute subscore of 0-1 [ Time Frame: 8 weeks post initial treatment ]
  • Progression of disease defined by initiation of anti-TNF agents or Corticosteroids: Initiation of anti-TNF agents (such as infliximab, adalimumab, certolizumab, vedolizumab and steroids). Includes time gap until additional agents are started. [ Time Frame: 2, 4 and 8 weeks post initial FMT ]
  • Progression of disease defined by increase in dosages of current UC medications [ Time Frame: 2, 4 and 8 weeks post initial FMT ]
  • Progression of disease defined by time to colectomy [ Time Frame: up to one year post initial FMT ]
  • Time to death secondary to UC [ Time Frame: up to one year post initial FMT ]
  • Progression of disease defined by clinical flare (Time to next flare) [ Time Frame: 2, 4 and 8 weeks post initial FMT ]
  • Increase in Quality of Life (based on RAND SF-36 survey and score) [ Time Frame: 8 weeks post initial FMT ]
  • Changes in Mood/Depression Score (based on PHQ-9 survey and score) [ Time Frame: 8 weeks post initial FMT ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Official Title  ICMJE Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Brief Summary This is a prospective unblinded, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.
Detailed Description

This is a prospective open-label, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.

This trial involves 11 study visits at UCSF in San Francisco, CA.

The routes of administration will be via colonoscopy for all subjects with maintenance therapy administered orally (i.e. using encapsulated FMT) for half of the subjects and per rectum by enema in the other half of the subjects. Additionally, the utility of pretreatment antibiotics will be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
    Delivered by colonoscopy, enema or orally (as capsules)
  • Other: pretreatment antibiotics
    5 day course (vancomycin PO 500mg bid, metronidazole PO 500mg bid, and neomycin PO 500mg bid) starting 6 days prior FMT
    Other Name: vancomycin, metronidazole, neomycin
Study Arms  ICMJE
  • Experimental: 1
    pretreatment antibiotics + FMT delivered by colonoscopy + FMT capsules per week x 6 weeks
    Interventions:
    • Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
    • Other: pretreatment antibiotics
  • Experimental: 2
    no antibiotics, FMT delivered by colonoscopy + FMT capsules per week x 6 weeks
    Intervention: Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
  • Experimental: 3
    pretreatment antibiotics + FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
    Interventions:
    • Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
    • Other: pretreatment antibiotics
  • Experimental: 4
    no antibiotics, FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
    Intervention: Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 28, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with history of mild to moderate Ulcerative Colitis confirmed by endoscopy and pathology.
  • Total Mayo score 4-9, endoscopic subscore ≥1; patients who have not had endoscopic evaluation within one year of enrollment will have flexible sigmoidoscopy for evaluation.
  • Age 18 - 64 and deemed otherwise healthy at the discretion of the investigator.
  • Concurrent therapies with mesalamine (stable x 4 weeks), immunomodulators (stable x 3 months), and biologic agents (stable x 3 months) will be allowed to continue during study.
  • If patient is on prednisone, the dose must be ≤ 10mg/day at the time of treatment and will be weaned by 2.5mg/week during the study period.

Exclusion Criteria:

  • Severe or refractory UC defined as Mayo score ≥10, endoscopic disease activity score 3
  • Untreated enteric infection (positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the investigator.
  • History of colectomy
  • Disease limited to distal proctitis
  • Patients taking probiotics within 6 weeks of planned FMT therapy.
  • Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy or radiation therapy)
  • Patients with the following laboratory abnormalities: absolute neutrophil count (ANC) < 1000 / µl, platelets <50 x 10^9 /L,, hemoglobin <6.5 g/dL..
  • History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish)
  • Dysphagia (oropharyngeal, esophageal, functional, neuromuscular)
  • History of recurrent aspiration episodes
  • Documented severe gastroparesis
  • Active intestinal obstruction
  • Patients with renal insufficiency (GFR < 50ml/min)
  • Allergy to the following generally regarded as safe ingredients (GRAS): glycerol, acid resistant HPMC, gellan gum, cocoa butter, titanium dioxide
  • Adverse event attributable to any previous FMT
  • Allergy/intolerance to proton pump inhibitor therapy
  • Allergy/intolerance to vancomycin, metronidazole, or neomycin.
  • Non-steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month.
  • Cholestyramine use
  • Any condition in which the investigator thinks the FMT treatment may pose a health risk (e.g. severely immunocompromised)
  • Simultaneous participation in another interventional clinical trial
  • Patients who are pregnant, breast feeding or planning pregnancy during study trial period.
  • During the trial period until one week after the trial end: Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device (IUD), hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment) or well-founded doubt about the patient's cooperation
  • Patients with any other significant medical condition that could confound or interfere with evaluation of safety, tolerability or prevent compliance with the study protocol at the discretion of the investigator
  • Life expectancy <6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006809
Other Study ID Numbers  ICMJE 16-20066
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Najwa Elnachef, University of California, San Francisco
Study Sponsor  ICMJE Najwa Elnachef
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP