Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Fecal Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328922
• Other study ID #: TASMC-16-NH-0123-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: January 2023

Study information

• Verified date: March 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Microbial Substitution

Intervention

Other:
• Fecal microbial transplantation
Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
• Placebo capsuls
capsules of glycerol and saline (placebo).

Locations

Country	Name	City	State
Israel	Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Department of Gastroentherology	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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 )	week 14
Secondary	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	week 22
Secondary	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	week 46
Secondary	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	week 46
Secondary	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	week 46
Secondary	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	week 46
Secondary	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	week 14
Secondary	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	week 22
Secondary	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	week 46
Secondary	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	week 46