Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
NCT02343562 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2018-01-30
Summary
Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.
Conditions
- Hirschsprung Disease
Interventions
- DIETARY_SUPPLEMENT
-
Probiotics
Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.
- DIETARY_SUPPLEMENT
-
Placebo
Multivitamin off-the-counter.
Sponsors & Collaborators
-
Cairo University
lead OTHER
Principal Investigators
-
Mahmoud MA Elfiky, M.D. · Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- Egypt
Study Locations
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