Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)

Completed · Phase 2 · Has a placebo group

Conditions studied: Hirschsprung Disease

In brief

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.

Key facts

Study ID

NCT00630838

Run by

University of Michigan

People needed

62

Starts

2006-09-01

Expected to finish

2010-09-01

Last updated by the study team

2016-07-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospital of Buffalo — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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