Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

Completed · Phase 1

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID: NCT03006809
Run by: Najwa Elnachef
People needed: 30
Starts: 2017-03-02
Expected to finish: 2021-04-04
Last updated by the study team: 2021-04-28

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

UCSF Division of Gastroenterology at Mount Zion — San Francisco, California, United States

Full record on ClinicalTrials.gov

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