Clinical Trial: Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
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 Summary:
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 treatment for HD.
E.1. Design: This study will be a prospectively performed, multi-center, double blinded, study drug versus placebo controlled study. It will test the hypothesis that post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC E.2. Study medication: VSL#3 (VSL Pharmaceuticals, Inc., Ft. Lauderdale, FL) was provided in packets, each of which contained 900 billion viable lyophilized bacteria of 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus). Maize starch was included as filler. Placebo was provided in identical bags containing 3 g of maize starch. VSL#3 and placebo were administered once each night. The taste and smell of the active drugs were not readily identifiable.
E.2.1. Formulation of the study drug: The drug will be delivered to patient's families in individual packets. The families will be instructed to administer the probiotic as appropriately diluted in 2 ounces of either expressed human milk or formula.
E.2.2. FDA approval number: VSL#3 is now a "medical food" in the US and does not need FDA approval.
E.2.3. Medication suppliers: VSL Pharmaceuticals, Inc., Ft. Lauderdale, FL E.2.4.Funds for medication: It is anticipated that the VSL Pharmaceutical Corporation will donate sufficient drug and placebo for the completion
Sponsor: University of Michigan
Current Primary Outcome:
- Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). [ Time Frame: 6 months post-pullthrough ]The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.
- Severity of Clinical Episodes of HAEC [ Time Frame: 6 months ]The severity of clinical episodes of HAEC will be stratified into three grades (mild, moderate, or severe). Grades of severity reported are based on first episodes.
Original Primary Outcome: The primary outcome measure will be the diagnosis of Hirschsprung-associated enterocolitis (HAEC). [ Time Frame: 6 months post-pullthrough ]
Current Secondary Outcome:
Original Secondary Outcome: Secondary outcome measures will be to measure the expression of MUC-2 and MUC-3 expressed proteins in the stools of study patients. Mucins will be detected by using a modified Western immunoblot technique of stool specimens as previously described [ Time Frame: 6 months post-pullthrough ]
Information By: University of Michigan
Dates:
Date Received: February 28, 2008
Date Started: September 2006
Date Completion:
Last Updated: June 7, 2016
Last Verified: April 2015
