Crohn's Disease Clinical Trial
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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||
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Phase 1 | |
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||
| Completed |
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| Terminated |
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|
Phase 2 | |
| Completed |
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| Active, not recruiting |
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| Completed |
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Phase 3 |