Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

  • STATUS
    Recruiting
  • days left to enroll
    48
  • participants needed
    80
  • sponsor
    Tel-Aviv Sourasky Medical Center
Updated on 3 March 2022
remission
vedolizumab
crohn's disease

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 5HBI15, 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.

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 5HBI15, 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.

Details
Condition Crohn Disease, Microbial Substitution
Treatment Fecal Microbial Transplantation, Placebo capsuls
Clinical Study IdentifierNCT04328922
SponsorTel-Aviv Sourasky Medical Center
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5HBI15
Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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