Phase 2
N=62
Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Hirschsprung Disease
Bottom Line
View on ClinicalTrials.gov: NCT00630838 ↗Enrolled (actual)
62
Serious AEs
28.3%
Results posted
Jul 2016
Primary outcome: Primary: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). — 10; 7 participants — p==0.897
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VSL#3 (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). |
10; 7 | =0.897 |
| PRIMARY Severity of Clinical Episodes of HAEC |
3; 6; 6; 0; 1; 1 | — |
Summary
Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.
Eligibility Criteria
Inclusion Criteria
- Patients eligible for enrollment will include all pediatric patients suffering from HD at an age of 12 months or younger. All patients will require consent by either parent or adult guardian
Exclusion Criteria
- Patients will be excluded if children that are deemed hemodynamically unstable and require immediate operative intervention, age more than one year of age, as this may mean very delay in diagnosis and may affect the study results, or infants having major congenital anomalies with short life expectancy. Additional exclusion criteria are those patients' parents or adult guardian who refuse to undergo randomization. Finally, those children who are transferred to another non-participating hospital will be excluded.
Data sourced from ClinicalTrials.gov (NCT00630838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.