NCT04328922

Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

Fecal Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 disease (CD) patients. Primary objective: To determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in higher remission rates in CD patients. 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 index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab. Study procedure: Study participants will receive FMT within a week prior to first vedolizumab infusion. All patients will be followed for 46 weeks in 8 visits at the IBD clinic in the GI department of the Tel Aviv Medical Center.

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 index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess) will be enrolled in the study. Follow-up: All patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup. Side effects (SE): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. Also, patients will receive direct contact details of both the study coordinator and the study PI.

Conditions

• Crohn Disease
• Microbial Substitution

Interventions

Type	Name	Description
OTHER	Fecal microbial transplantation	Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
OTHER	Placebo capsuls	capsules of glycerol and saline (placebo).

Timeline

• Start date: 2018-07-03
• Primary completion: 2022-04-01
• Completion: 2023-01-01
• First posted: 2020-04-01
• Last updated: 2020-04-01

Locations

2 sites across 1 country: Israel