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

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ClinicalTrials.gov Identifier: NCT00630838
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel H. Teitelbaum, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Hirschsprung Disease Drug: VSL#3 Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Study Start Date : September 2006
Primary Completion Date : September 2010
Study Completion Date : September 2010


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel H. Teitelbaum, Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT00630838     History of Changes
Other Study ID Numbers: VSL-N007177
First Posted: March 7, 2008    Key Record Dates
Results First Posted: July 19, 2016
Last Update Posted: July 19, 2016
Last Verified: April 2015

Keywords provided by Daniel H. Teitelbaum, 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