Overview
Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Status:
Completed
Completed
Trial end date:
2010-09-01
2010-09-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Michigan
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.