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Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Broad Foundation
Brigham and Women's Hospital
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01847170
First received: May 2, 2013
Last updated: August 14, 2014
Last verified: August 2014

May 2, 2013
August 14, 2014
May 2013
September 2014   (final data collection date for primary outcome measure)
  • Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Recipients' fecal microbial diversity after FMT, when compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01847170 on ClinicalTrials.gov Archive Site
  • Recipients' fecal microbial diversity at 4 and 8 weeks after FMT, when compared to baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean change in Harvey Bradshaw Index (HBI) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients in clinical remission (those with an HBI score at week 12 <5) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in Short Inflammatory Bowel Disease Questionnaire (sIBDQ) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients in endoscopic remission (CDEIS score <3) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with mucosal healing (CDEIS score <1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in CRP levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in Crohn's Disease Endoscopic Index of Severity (CDEIS) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Tolerability score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease
Not Provided

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Crohn's Disease
Biological: Fecal Microbial Transplantation
Other Names:
  • Fecal Transplant
  • Stool transplant
Experimental: Fecal Microbial Transplantation
Intervention: Biological: Fecal Microbial Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01847170
2012P-000353
Yes
Alan C. Moss, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • Broad Foundation
  • Brigham and Women's Hospital
Principal Investigator: Alan C Moss, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP