Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease (FMT-IBD)

This is an interventional treatment trial for Fecal Microbiota Transplantation focused on measuring Ulcerative Colitis, Crohn's disease Read More

Inclusion Criteria:

• Age 18-75 years inclusive (no limit on gender)
• Confirmed diagnosis of ulcerative colitis for > 3 months, according to established clinical,endoscopic and histologic criteria
• Currently active mild-moderate ulcerative colitis, as measured by a Mayo score of 4-10, in which endoscopy sub-score ≥ 1 and physician's global assessment sub-score ≤ 2
• Written informed consent obtained.

Exclusion Criteria:

• Subjects who are unable to give consent or who have conditions rendering them incapable to answer questionnaires or provide samples.
• Females who are pregnant or actively trying to fall pregnant
• Subjects unwilling to practice an effective method of contraception throughout the study period
• Subjects defined as in remission by the investigator
• Evidence or history of toxic megacolon
• Isolated proctitis < 5 cm
• A diagnosis of Crohn's Disease or indeterminate colitis
• Subjects with perianal disease (e.g. fistulae, pre-existing fissures)
• Significant gastrointestinal surgery e.g. colon resection, colectomy :Minor gastrointestinal surgery will be reviewed on a case by case basis by the investigator;Regarding appendicectomy, only exclude patients who had appendicectomy < 3 months ago)
• Subjects taking antimicrobials (antibiotics, antifungals, antivirals) for any reason, including antibiotics for ulcerative colitis, in the preceding 4 weeks
• Subjects who are steroid dependent and requiring > 20mg prednisone or > 9mg budesonide daily at the time of enrolment
• Subjects who have recently taken or are actively taking or expected to require prohibited medication/s during the study period including follow-up. These include:Rectal therapy including corticosteroid, 5-aminosalicylate within 2 weeks before first FMT;Treatment with biologic agents e.g. infliximab, adalimumab, vedolizumab, within 12 weeks before first FMT;Treatment with other major immunosuppressant agents including calcineurin inhibitors, anti-neoplastic agents, lymphocyte depleting biological agents within 12 weeks before first FMT;Probiotic therapy within 4 weeks before first FMT;Experimental / trial drug protocol involvement within 12 weeks before first FMT;Anti-mycobacterial (TB or MAC) therapy within 4 weeks before first FMT

Allowed concomitant medications:

The following drugs are allowed as long as the dose is stable preceding first FMT for the noted time:

• oral 5-aminosalicylates (stable dose for 4 weeks)
• thiopurines and methotrexate (on medication for ≥ 90 days and dose stable for 4 weeks)
• oral prednisolone (dose ≤ 20mg daily and stable for 2 weeks) During the study, subjects should remained on the same dose of oral 5-aminosalicylate, thiopurine, and methotrexate. For oral prednisolone, dose must be tapered at a rate up to 2.5mg per week so that subjects would be steroid-free by week 8.

Prohibited medications:

The following drugs for are prohibited for the noted time:

• Rectal therapies including corticosteroid, 5-aminosalicylate (for 2 weeks before first FMT and during study period)
• Antibiotics, antibiotics, antifungals, antivirals, probiotic or prebiotic preparations (for 4 weeks before first FMT and during study period)
• Rectal therapies including corticosteroid, 5-aminosalicylate (for 2 weeks before first FMT and during study period)
• Biological therapies or calcineurin inhibitors (for 12 weeks before first FMT and during study period)