Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
2 other identifiers
interventional
40
1 country
1
Brief Summary
Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 30, 2018
January 1, 2018
4.2 years
January 9, 2015
January 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of Hirschsprung's associated enterocolitis (HAEC)
Absence of HAEC symptoms and signs; absence of fever, abdominal distension, loose stools (diarrhea) , bloody stools during the postoperative period for 6 months.
6 months
Secondary Outcomes (1)
Improvement of stooling pattern of postoperative Hirschsprung's cases
6 months
Study Arms (2)
Probiotics Group
ACTIVE COMPARATORWill receive Sachet-form probiotics
Placebo Group
PLACEBO COMPARATORWill receive off-the-shelf oral multivitamin
Interventions
Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.
Eligibility Criteria
You may qualify if:
- Hirschsprungs disease confirmed preoperative and postoperative specimen pathology
You may not qualify if:
- Other cases of Enterocolitis and constipation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University Pediatric Hospital
Cairo, 11432, Egypt
Related Publications (2)
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: 23331802BACKGROUNDDemehri, Farokh R., et al.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud MA Elfiky, M.D.
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Probiotic Sachets
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Pediatric Surgery
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 22, 2015
Study Start
October 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 30, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share