ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03006809
Previous Study | Return to List | Next Study

Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03006809
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Najwa Elnachef, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: Fecal Microbiota Transplantation (FMT), OpenBiome Other: pretreatment antibiotics Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Neomycin

Arm Intervention/treatment
Experimental: 1
pretreatment antibiotics + FMT delivered by colonoscopy + FMT capsules per week x 6 weeks
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

Experimental: 2
no antibiotics, FMT delivered by colonoscopy + FMT capsules per week x 6 weeks
Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
Delivered by colonoscopy, enema or orally (as capsules)

Experimental: 3
pretreatment antibiotics + FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
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

Experimental: 4
no antibiotics, FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
Biological: Fecal Microbiota Transplantation (FMT), OpenBiome
Delivered by colonoscopy, enema or orally (as capsules)




Primary Outcome Measures :
  1. 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

  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Progression of disease defined by increase in dosages of current UC medications [ Time Frame: 2, 4 and 8 weeks post initial FMT ]
  5. Progression of disease defined by time to colectomy [ Time Frame: up to one year post initial FMT ]
  6. Time to death secondary to UC [ Time Frame: up to one year post initial FMT ]
  7. Progression of disease defined by clinical flare (Time to next flare) [ Time Frame: 2, 4 and 8 weeks post initial FMT ]
  8. Increase in Quality of Life (based on RAND SF-36 survey and score) [ Time Frame: 8 weeks post initial FMT ]
  9. Changes in Mood/Depression Score (based on PHQ-9 survey and score) [ Time Frame: 8 weeks post initial FMT ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006809


Locations
United States, California
UCSF Division of Gastroenterology at Mount Zion Recruiting
San Francisco, California, United States, 94143
Contact: Vivian Deng    415-514-8635    fmt@ucsf.edu   
Contact: Martin Zydek    415-514-8635    fmt@ucsf.edu   
Principal Investigator: Najwa El-Nachef, MD         
Sponsors and Collaborators
Najwa Elnachef

Responsible Party: Najwa Elnachef, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03006809     History of Changes
Other Study ID Numbers: 16-20066
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Najwa Elnachef, University of California, San Francisco:
Ulcerative colitis
FMT
fecal transplant

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Bacterial Agents
Vancomycin
Neomycin
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action