Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

NCT ID: NCT04328922

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2023-01-31

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.

Conditions

Crohn Disease; Microbial Substitution

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fecal microbial transplantation

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).

Group Type: ACTIVE_COMPARATOR

Fecal microbial transplantation

Intervention Type: OTHER

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo capsuls

Intervention Type: OTHER

capsules of glycerol and saline (placebo).

Interventions

Fecal microbial transplantation

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

Intervention Type: OTHER

Placebo capsuls

capsules of glycerol and saline (placebo).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Head of R&D development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Gastroentherology

Tel Aviv, , Israel

Site Status: RECRUITING

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Nitsan Maharshak, MD

Role: primary

nitsanm@tlvmc.gov.il

972-3-6972488

Nitsan Maharshak, MD

Role: primary

nitsanm@tlvmc.gov.il

972-3-6947305

Other Identifiers

TASMC-16-NH-0123-CTIL

Identifier Type: -

Identifier Source: org_study_id