Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

Open to people ages 18-64

• 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.

• 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 10⁹ /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