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

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00630838
First received: February 28, 2008
Last updated: July 12, 2011
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hirschsprung Disease
Drug: VSL#3
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The primary outcome measure will be the diagnosis of Hirschsprung-associated enterocolitis (HAEC). [ Time Frame: 6 months post-pullthrough ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: September 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
VSL#3 probiotic
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.

Placebo Comparator: 2
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
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

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  Eligibility

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630838

Locations
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, New York
Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Daniel H Teitelbaum, MD University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel H. Teitelbaum, University of Michigan
ClinicalTrials.gov Identifier: NCT00630838     History of Changes
Other Study ID Numbers: VSL-N007177
Study First Received: February 28, 2008
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Hirschsprung disease
enterocolitis
probiotics

Additional relevant MeSH terms:
Enterocolitis
Hirschsprung Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Digestive System Abnormalities
Megacolon
Colonic Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 23, 2014