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

NCT00630838 | Completed Phase 2 Results DMC

• 1 other identifier: VSL-N007177
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Hirschsprung Disease

Keywords

Hirschsprung disease; enterocolitis; probiotics

Outcome Measures

Primary Outcomes (2)

• Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).

  The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.

  6 months post-pullthrough

• Severity of Clinical Episodes of HAEC

  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.

  6 months

Study Arms (2)

1

EXPERIMENTAL

VSL#3 probiotic

Drug: VSL#3

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VSL#3 DRUG

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.

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

Related Publications (1)

• El-Sawaf M, Siddiqui S, Mahmoud M, Drongowski R, Teitelbaum DH. Probiotic prophylaxis after pullthrough for Hirschsprung disease to reduce incidence of enterocolitis: a prospective, randomized, double-blind, placebo-controlled, multicenter trial. J Pediatr Surg. 2013 Jan;48(1):111-7. doi: 10.1016/j.jpedsurg.2012.10.028.

  PMID: 23331802 DERIVED

MeSH Terms

Conditions

Hirschsprung Disease; Enterocolitis

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastroenteritis

Limitations and Caveats

The secondary outcome measure was defined before beginning the study as the measure of the expression of MUC-2 and MUC-3 expressed proteins in the stools of study patients. However, stool samples were not collected and this analysis was not done.

Results Point of Contact

• Title: Daniel Teitelabum
• Organization: University of Michigan

dttlbm@umich.edu

734-936-8464

Study Officials

• Daniel H Teitelbaum, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: September 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 19, 2016
• Results First Posted: July 19, 2016

Record last verified: 2015-04

Locations

US (2)