Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)

Crohn's Disease Clinical Trial

— FMT  

Official title:

Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02417974
• Other study ID #: H-34244
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: February 4, 2021

Study information

• Verified date: February 2022
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Patients):

• Adults (age > 18)

• Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging (confirmed by Study PI for each site)

• Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to enrollment

• Resection margins & anastomosis free of active inflammation based on histology and surgical description (confirmed by Study PI for each site)

• No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior to enrollment.

Exclusion Criteria (Patients):

• Diagnosis of indeterminate colitis

• Women who are pregnant or nursing

• Patients who are unable to give informed consent

• Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)

• Patients who have previously undergone FMT

• Patients who have a confirmed malignancy or cancer

• Participation in a clinical trial in the preceding 30 days or simultaneously during this trial

• Probiotic use within 30 days of start date

• Decompensated cirrhosis

• Congenital or acquired immunodeficiencies

• Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44

• History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia from colonoscopy

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Recurrence

Intervention

Biological:
• Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Medical Center	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Endoscopic Recurrence	Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2	within 6 months of ileo-cecal resection
Secondary	Change in Microbial Diversity: Shannon Diversity Index	The Shannon Diversity Index is a measure of entropy and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -S p_i log(p_i). Lower values indicate more diversity while higher values indicate less diversity.	baseline, 4, 12, and 26 weeks
Secondary	Number of Participants in Clinical Remission at 26 Weeks	Clinical remission is defined as having a Harvey Bradshaw Index (HBI) score <5 at week 26. The HBI can range from 0 to 18 and higher scores are associated with more severe disease.	26 weeks
Secondary	Adverse Events Frequency	Number of participants with adverse events	4, 12, and 26 weeks