Status:
COMPLETED
Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Lead Sponsor:
University of Michigan
Conditions:
Hirschsprung Disease
Eligibility:
All Genders
1-12 years
Phase:
PHASE2
Brief 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.
Detailed Description
To test the hypothesis that probiotics will decrease the risk of post pull-through enterocolitis by randomizing patients to receive either probiotics or placebo for the first 3 months after surgical t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00630838
Start Date
September 1 2006
End Date
September 1 2010
Last Update
July 19 2016
Active Locations (2)
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1
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
2
Children's Hospital of Buffalo
Buffalo, New York, United States, 14222