Ulcerative Colitis
Conditions
Keywords
Microbiota, Ulcerative Colitis
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.
Interventions
PROCEDUREColonoscopy
Fecal microbiota transplantation through colonoscopy
PROCEDUREGastroscopy
Fecal microbiota transplantation through gastroscopy
DRUGFecal Microbiota
PROCEDUREEnema
Fecal microbiota transplantation through enema
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 8 weeks after FMT | A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological remission assessed by sigmoidoscopy | 8 weeks after FMT | Will be assessed by sigmoidoscopy |
| Long term remission assessed through questionnaires | one year after FMT | Will be assessed through questionnaires |
Countries
Israel
Outcome results
None listed