Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
Phase 2
Terminated
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT04434872
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).
FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.
Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.
At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.
Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Over 3 month diagnosis of ulcerative colitis
- Active Colitis disease with endoscopic score >0
- Ability to sign an informed consent
Exclusion Criteria
- Acute neutrophilia (under 500 neutrophils)
- Clostridium difficile infection
- Exposure to antibiotics 2 weeks prior to enrollment.
- Severe immune deficiency
- Hospitalization
- Proctitis involving less than 10cm of the rectum
- Malignancy with the past 5 years (excluding BCC)
- An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMT from a healthy donor Colonoscopy Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a healthy donor Enema Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a self donated stool sample Gastroscopy Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a healthy donor Gastroscopy Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a self donated stool sample Colonoscopy Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a self donated stool sample Enema Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a healthy donor Fecal Microbiota Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. FMT from a self donated stool sample Fecal Microbiota Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
- Primary Outcome Measures
Name Time Method Clinical improvement 8 weeks after FMT A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE
- Secondary Outcome Measures
Name Time Method Long term remission assessed through questionnaires one year after FMT Will be assessed through questionnaires
Histological remission assessed by sigmoidoscopy 8 weeks after FMT Will be assessed by sigmoidoscopy
Trial Locations
- Locations (1)
Department of Gastroentherology
🇮🇱Tel Aviv, Israel
Department of Gastroentherology🇮🇱Tel Aviv, Israel