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NCT01972334 · ClinicalTrials.gov registry record · Phase 2
Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection
A Phase 2 study, sponsored by MemorialCare Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01972334: Completed Phase 2 study, sponsored by MemorialCare Health System.
NCT01972334 is a Phase 2 study that has completed, run by MemorialCare Health System. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01972334, a Phase 2 study, has completed, sponsored by MemorialCare Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. A well known and common example is the use of antibiotics. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance. To this date there have been a great number of reports of success in eliminating recurrent C. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. While over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. Therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. The investigators hypothesize that children with recurrent C. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. The investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent C. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent C. difficile infection. The investigators anticipate that fecal microbial transplant in children with recurrent C. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. Results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.
Primary Outcome
secondary outcome measures are focused on the safety of Fecal microbial transplant in this population and all subjects will be closely monitored for developing adverse events for 12 months
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL FMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT01972334 record still lists
NCT01972334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01972334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01972334 about?
NCT01972334 is a clinical study titled "Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection". The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 b...
What is the current status of trial NCT01972334?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2013-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01972334?
The interventions under investigation include: placebo (BIOLOGICAL), FMT (BIOLOGICAL).
Who is sponsoring clinical trial NCT01972334?
This trial is sponsored by MemorialCare Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01972334's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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