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

PHASE2CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Hirschsprung Disease
Interventions
DRUG

VSL#3

"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."

DRUG

Placebo

Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months

Trial Locations (2)

14222

Children's Hospital of Buffalo, Buffalo

48109

C.S. Mott Children's Hospital, Ann Arbor

All Listed Sponsors
lead

University of Michigan

OTHER

NCT00630838 - Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC) | Biotech Hunter | Biotech Hunter