Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

NCT04328922 | Unknown

• 1 other identifier: TASMC-16-NH-0123-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn Disease; Microbial Substitution

Outcome Measures

Primary Outcomes (4)

• safety 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.

  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.

  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

  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

  week 46

Secondary Outcomes (10)

• efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate

  week 14

• efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate

  week 22

• efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate

  week 46

• efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response

  week 46

• efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission

  week 46

Study Arms (2)

Fecal microbial transplantation

ACTIVE COMPARATOR

FMT capsules fecal capsules on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion. Patients who will be allocated to this treatment arm will be matched to donors according to their CMV status (past exposure - CMV positive donors will be used for CMV positive patients, and CMV negative donors will be used for CMV negative patients).

Other: Fecal microbial transplantation

Placebo

PLACEBO COMPARATOR

Placebo capsules placebo capsules- on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion. Patients who will be allocated to this treatment arm will receive placebo capsules.

Other: Placebo capsuls

Interventions

Fecal microbial transplantation OTHER

Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/

Fecal microbial transplantation

Placebo capsuls OTHER

capsules of glycerol and saline (placebo).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (2)

Department of Gastroentherology

Tel Aviv, 64239, Israel

RECRUITING

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, treating physician and study investigators will be blinded to the treatment intervention (FMT/ placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of R&D development

Model Details: A randomized double blinded controlled clinical trial

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: April 1, 2020
• Study Start: July 3, 2018
• Primary Completion: April 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)