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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
capsules of glycerol and saline (placebo).
Department of Gastroentherology
Tel Aviv, Israel
RECRUITINGDep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGsafety of FMT pre vedolizumab treatment in CD patients
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
Time frame: week 14
safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 14
Time frame: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 46
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in clinical response rate (reduction in HBI≥3 )
Time frame: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
Time frame: week 22
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in endoscopic response that will be defined as a decrease of ≥50% in SES-CD score / improvement in Rutgeerts score ≥1, compared to baseline colonoscopy
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in Endoscopic remission at week 46 will be defined as SES-CD ≤2 or Rutgeerts score ≤1 , compared to baseline colonoscopy
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in histological healing compared to week 0
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin\<150mg/kg and CRP\<5mg/L
Time frame: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin\<150mg/kg and CRP\<5mg/L
Time frame: week 22
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin\<150mg/kg and CRP\<5mg/L
Time frame: week 46
safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in lower adverse events rate of intervention versus placebo
Time frame: week 46
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