Status:
UNKNOWN
Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Crohn Disease
Microbial Substitution
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's d...
Detailed Description
Study design: A randomized double blinded controlled clinical trial. Study population: CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw inde...
Eligibility Criteria
Inclusion
- Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
- Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)
Exclusion
- CD patients in remission (HBI\<5) or with sever disease (HBI\>16)
- Patients with a stoma
- Hospitalized patients
- Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
- Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
- Pregnant/lactating women
- Inability to sign an informed consent
- Inability to complete the study protocol
- An ongoing or planned antibiotics therapy
- Severe food allergies
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04328922
Start Date
July 3 2018
End Date
January 1 2023
Last Update
April 1 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gastroentherology
Tel Aviv, Israel, 64239
2
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel