Stool transplant as treatment in ulcerative colitis

Phase 2/3

Recruiting

Brief Summary: The role of gut microbiome in health and inflammation has gained international attention in recent times. The success of fecal microbiota transplantation (FMT) (a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with the goal being to introduce or restore a stable microbial community in the gut) in treatment of *Clostridium difficile* infection led to the hypothesis that it may play an important role in Inflammatory Bowel Disease (IBD) as well. Randomized controlled trials have demonstrated efficacy of FMT in induction of remission in mild-moderate Ulcerative Colitis (UC). However there is paucity of data which looks into the role of FMT in maintenance of remission in Ulcerative Colitis. This study aims to study the role of fecal microbiota transplantation in maintenance of remission in UC. Patients will receive retention enemas or through colonoscopy and will be looked for remission/response at 6 months and 1 year.

Recruitment & Eligibility

Inclusion Criteria

Confirmed Ulcerative Colitis patients who are in clinical remission (defined as complete resolution of symptoms) for a minimum duration of 6 months.
Patients must be on stable medication regimen for at least 6 months prior to enrollment.
Able to give informed consent and/or assent as appropriate.

Exclusion Criteria

Patients with active disease 2.
Patients having toxic megacolon 3.
Treatment naÃ¯ve patients 4.
Pregnant and lactating ladies 5.
Prior colectomy 6.
Positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, E.
coli by standard stool culture.
Regular probiotic supplement use within prior 4 weeks to enrollment 8.
Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy) 9.
Patients unwilling or unable to give consent or participate in all study requirements.

Primary Outcome Measures

Name	Time	Method
Comparison of clinical response in two groups	One Year

Secondary Outcome Measures

Name	Time	Method
Comparison of Endoscopic activity of Ulcerative Colitis	1 year

Locations (1): Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana
🇮🇳
Ludhiana, PUNJAB, India
Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana
🇮🇳Ludhiana, PUNJAB, India
Arshdeep Singh
Principal investigator
9815337764
drarshdeepsingh@gmail.com