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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847170
First Posted: May 6, 2013
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Broad Foundation
Brigham and Women's Hospital
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
  Purpose

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.


Condition Intervention Phase
Crohn's Disease Biological: Fecal Microbial Transplantation Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Alan C. Moss, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events [ Time Frame: 24 weeks ]
  • Recipients' fecal microbial diversity after FMT, when compared to baseline [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Recipients' fecal microbial diversity at 4 and 8 weeks after FMT, when compared to baseline [ Time Frame: 8 weeks ]
  • Mean change in Harvey Bradshaw Index (HBI) score [ Time Frame: 12 weeks ]
  • Percentage of patients in clinical remission (those with an HBI score at week 12 <5) [ Time Frame: 12 weeks ]
  • Mean change in Short Inflammatory Bowel Disease Questionnaire (sIBDQ) score [ Time Frame: 12 weeks ]
  • Percentage of patients in endoscopic remission (CDEIS score <3) [ Time Frame: 12 weeks ]
  • Percentage of patients with mucosal healing (CDEIS score <1) [ Time Frame: 12 weeks ]
  • Mean change in CRP levels [ Time Frame: 12 weeks ]
  • Mean change in Crohn's Disease Endoscopic Index of Severity (CDEIS) score [ Time Frame: 12 weeks ]
  • Tolerability score [ Time Frame: 2 weeks ]

Enrollment: 22
Study Start Date: May 2013
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal Microbial Transplantation Biological: Fecal Microbial Transplantation
Other Names:
  • Fecal Transplant
  • Stool transplant

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847170


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
The Broad Foundation
Brigham and Women's Hospital
Investigators
Principal Investigator: Alan C Moss, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Alan C. Moss, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01847170     History of Changes
Other Study ID Numbers: 2012P000353
First Submitted: May 2, 2013
First Posted: May 6, 2013
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases