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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
Completed |
NCT01951326 -
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
|
Phase 3 |