Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease
|Ulcerative Colitis Crohn Disease Constipation (Excl Faecal Impaction)||Biological: Fecal microbiota transplantation||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease|
- Patients with worsened disease [ Time Frame: one year ]Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.
- Adverse events [ Time Frame: one year ]Number of adverse events
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||May 2020|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Fecal microbiota transplantation
Fecal microbiota transplantation only
Biological: Fecal microbiota transplantation
Fecal microbiota transplantation to patients with ulcerative colitis and Crohn disease
Intestinal microbiota have a major role in disease pathogenesis, either in a form of a "permissive" role or as a direct pathogenic cause.
Clostridium difficile colitis; irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) have all been connected to a disturbance in the equilibrium of intestinal microbiome. The cause of IBD in unknown but evidence is getting that immense immune reaction of intestinal immune system to microflora combined with a genetic predisposition are responsible for the chronic inflammation.
Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The fecal material of a healthy individual is fluidized and that inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. Previous work had shown success in fecal transplantation as a treatment for clostridium difficile colitis. There are also reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small. 41 cases were reported , In some the FMT was inserted through a nasogastric tube directly to the duodenum, in some be colonoscopy and in some by an enema. A significant clinical improvement was reported in 19 of 25 patients. 13 of 17 stopped IBD treatment , 15 of 24 entered full clinical remission. In all 15 patients treated for infection the treatment was successful. No sever adverse effects were reported, Fever was developed in 8 cases and in one case there was exacerbation of colitis after treatment.
Primary aim: To investigate whether use of FMT will bring improvement of at least 2 points in partial mayo score in ulcerative colitis patients, or 75 points in CDAI of patients with Crohn's colitis. One month after FMT.
Improvement will be defined as:
For Ulcerative colitis: a decrease of at least 2 points in the partial mayo score, and a decrease of at least 1 point in endoscopic Mayo score.
For Crohn's disease: A decrease of at least 70 points in Crohn's disease activity index (CDAI).
80 patients aged >18 years, with histological and endoscopic diagnosis of ulcerative colitis (UC) or CD who did not respond to either thiopurines or tumor necrosis factor (TNF) inhibitors.
Flare will be defined as partial mayo score higher then 3, with either C reactive protein (CRP) higher than 6 or endoscopic mayo score >1 in ulcerative colitis and CDAI higher them 220 and CRP higher than 6 in Crohn's colitis.
Stool will be donated by the patients choice either from a relative, preferably a partner to minimize possible transference of an infective agent, alternatively samples will be ordered from "open biom".
Please refer to this study by its ClinicalTrials.gov identifier: NCT02575040
|Contact: Hakan Demirci, M.D.||firstname.lastname@example.org|
|Gulhane Military Medical Academy||Recruiting|
|Ankara, Turkey, 06010|
|Contact: Hakan Demirci, M.D. 00905325140028 email@example.com|
|Principal Investigator:||Ahmet Uygun, Prof||Gulhane Military Medical Academy, Department of Gastroenterology|