Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease
- Conditions
- Crohn's Disease
- Interventions
- Biological: Fecal Microbial Transplantation
- Registration Number
- NCT01847170
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fecal Microbial Transplantation Fecal Microbial Transplantation -
- Primary Outcome Measures
Name Time Method Recipients' fecal microbial diversity after FMT, when compared to baseline 12 weeks Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events 24 weeks
- Secondary Outcome Measures
Name Time Method Recipients' fecal microbial diversity at 4 and 8 weeks after FMT, when compared to baseline 8 weeks Mean change in Short Inflammatory Bowel Disease Questionnaire (sIBDQ) score 12 weeks Percentage of patients with mucosal healing (CDEIS score <1) 12 weeks Mean change in CRP levels 12 weeks Percentage of patients in clinical remission (those with an HBI score at week 12 <5) 12 weeks Tolerability score 2 weeks Percentage of patients in endoscopic remission (CDEIS score <3) 12 weeks Mean change in Harvey Bradshaw Index (HBI) score 12 weeks Mean change in Crohn's Disease Endoscopic Index of Severity (CDEIS) score 12 weeks
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States