Clinical trial NCT04328922: Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease
Official title: Fecal Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Microbial Substitution
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized double blinded controlled clinical trial
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
2. Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)

Exclusion Criteria:

1. CD patients in remission (HBI\<5) or with sever disease (HBI\>16)
2. Patients with a stoma
3. Hospitalized patients
4. Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
5. Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
6. Pregnant/lactating women
7. Inability to sign an informed consent
8. Inability to complete the study protocol
9. An ongoing or planned antibiotics therapy
10. Severe food allergies

Primary outcomes:
measure: safety of FMT pre vedolizumab treatment in CD patients
timeFrame: week 14
measure: safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
timeFrame: week 46
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
timeFrame: week 14
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
timeFrame: week 46
Secondary outcomes:
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
timeFrame: week 14
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
timeFrame: week 22
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
timeFrame: week 46
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
timeFrame: week 46
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
timeFrame: week 46
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
timeFrame: week 46
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
timeFrame: week 14
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
timeFrame: week 22
measure: efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
timeFrame: week 46
measure: safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
timeFrame: week 46
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology
city: Tel Aviv
country: Israel
facility: Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Study officials:
References: