Trial record 4 of 5 for:
"Hirschsprungs disease"
Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
This study has been completed.
Sponsor:
University of Michigan
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00630838
First received: February 28, 2008
Last updated: July 12, 2011
Last verified: February 2008
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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
|
Show Detailed Description 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
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 May 19, 2013