Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01560819 · ClinicalTrials.gov registry record · Phase 1
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
A Phase 1 study of Inflammatory Bowel Disease (IBD), sponsored by Corewell Health West.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01560819: Completed Phase 1 study of Inflammatory Bowel Disease (IBD), sponsored by Corewell Health West.
NCT01560819 is a Phase 1 study of Inflammatory Bowel Disease (IBD) that has completed, run by Corewell Health West. The registered enrollment target is 20 participants, below the 272-participant average among 12 other Inflammatory Bowel Disease (IBD) trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560819, a Phase 1 study of Inflammatory Bowel Disease (IBD), has completed, sponsored by Corewell Health West.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC. This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up. Healthy donors \>18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
Primary Outcome
Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment
Conditions Studied
Interventions
- DRUG Gut Microbial Transplantation
Study Locations (1)
Michigan
- Helen DeVos Children's Hospital of Spectrum Health Hospitals - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01560819 record still lists
NCT01560819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 272-participant average among 12 other Inflammatory Bowel Disease (IBD) trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Inflammatory Bowel Disease (IBD) appearing as the primary indexed condition, and to 1 intervention - of which Gut Microbial Transplantation is the first listed.
NCT01560819 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01560819 about?
NCT01560819 is a clinical study titled "Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases". Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantat...
What is the current status of trial NCT01560819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-03. Estimated completion is 2013-06.
What conditions does trial NCT01560819 study?
This clinical trial studies the following conditions: Inflammatory Bowel Disease (IBD).
What interventions are being tested in trial NCT01560819?
The interventions under investigation include: Gut Microbial Transplantation (DRUG).
Who is sponsoring clinical trial NCT01560819?
This trial is sponsored by Corewell Health West, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01560819 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Inflammatory Bowel Disease (IBD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01560819's enrollment target sits among peer trials
20 13th of 12 the lowest of 12 other Inflammatory Bowel Disease (IBD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Disease (IBD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of KCC Peptide Application in the Colon
COMPLETED · Phase 1
-
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
RECRUITING
-
Study of DISC-0974-201 in Participants With IBD and Anemia
RECRUITING · Phase 2
-
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
RECRUITING
-
Evaluation of the SMART IBD App in Pediatric IBD
RECRUITING · NA
-
IBD Pregnancy Registry
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia