Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by MemorialCare Health System. The registered enrollment target is 9 participants.
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.
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL FMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01972334
The ClinicalTrials.gov registry entry for NCT01972334 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MemorialCare Health System, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01972334 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.