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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01847170
Other study ID # 2012P000353
Secondary ID
Status Completed
Phase Phase 1
First received May 2, 2013
Last updated March 2, 2017
Start date May 2013
Est. completion date November 2016

Study information

Verified date March 2017
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The human immune system is usually tolerant of the millions of beneficial commensal bacteria (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with Inflammatory Bowel Disease (IBD) may play host to an imbalanced mix of such intestinal bacteria, which initiates abnormal immune responses in susceptible individuals. The resulting inflammation that occurs in the gastrointestinal tract damages the intestinal lining, leading to symptoms (such as intractable diarrhea, pain or weight loss), heightened cancer risk, other serious complications with substantial morbidity and even death. Current therapies for IBD focus on suppressing the excessive immune response to these bacteria, but have major side effects and do not address any role of the microbiome in disease development.

The investigators hypothesize that there is heightened intraluminal generation of pro-inflammatory factors by luminal "pathogenic" bacteria, such as extracellular nucleotides and purinergic derivatives, which trigger host immune cells. This results in loss of suppressive T regulatory cells with unrestrained immune cell deviation to pathogenic T helper cells that cause inflammatory responses. The investigators' proposal is that correcting the disease-provoking microbiome would beneficially improve gut microbial diversity, alter immune responses elicited in patients by such microbial products of pathogenic bacteria, and ultimately limit and suppress disease activity.

To test the hypothesis, the investigators propose to enroll patients with active Crohn's Disease, and introduce the microbiome of healthy and unrelated individuals to patient's intestinal tract, via fecal biotherapy (FBT) with all applicable safety measures. The investigators propose to comprehensively test the effects of FBT on the host microbiome, determine microbial production of inflammatory nucleotides and derivatives, which the investigators suggest might impact the host immune response and disease activity in patients with IBD.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria (Patients):

- CD confirmed by biopsy for > 3 months duration

- Active disease (Harvey-Bradshaw Index > 5

- Failed standard therapy with; stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)

- Stable medication regimen for >2 weeks.

- Age > 18 years old

Exclusion Criteria (Patients):

- Diagnosis of indeterminate colitis, or proctitis alone

- Severe or fulminate 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

- Patients who are immunocompromised

- Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide

- Antibiotic use within 2-months of start date

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

- Probiotic use within 30 days of start date

- Rectal therapy within 14 days of start date

- Decompensated cirrhosis

- Congenital or acquired immunodeficiencies

- Other comorbidities including:

- Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy

- 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

- Steroid dose >20mg/day

Study Design


Intervention

Biological:
Fecal Microbial Transplantation


Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Brigham and Women's Hospital, The Broad Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events 24 weeks
Primary Recipients' fecal microbial diversity after FMT, when compared to baseline 12 weeks
Secondary Recipients' fecal microbial diversity at 4 and 8 weeks after FMT, when compared to baseline 8 weeks
Secondary Mean change in Harvey Bradshaw Index (HBI) score 12 weeks
Secondary Percentage of patients in clinical remission (those with an HBI score at week 12 <5) 12 weeks
Secondary Mean change in Short Inflammatory Bowel Disease Questionnaire (sIBDQ) score 12 weeks
Secondary Percentage of patients in endoscopic remission (CDEIS score <3) 12 weeks
Secondary Percentage of patients with mucosal healing (CDEIS score <1) 12 weeks
Secondary Mean change in CRP levels 12 weeks
Secondary Mean change in Crohn's Disease Endoscopic Index of Severity (CDEIS) score 12 weeks
Secondary Tolerability score 2 weeks
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