Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Phase 4

• Conditions: Hirschsprung Disease
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT02343562
• Lead Sponsor: Cairo University

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.

Detailed Description

Randomised Controlled Study with two arms. All cases following up for post operative Hirschsprungs surgery are included in this study. First arm will receive a probiotics in the form of sachet for 6 months. Second arm will receive a multivitamin as placebo. Comparative analysis between the two groups for baseline and followup prevalence of Hirschsprungs associated enterocolitis.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-27
• Last Update Posted: 2018-01-30
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria

• Other cases of Enterocolitis and constipation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics Group	Probiotics	Will receive Sachet-form probiotics
Placebo Group	Placebo	Will receive off-the-shelf oral multivitamin

Primary Outcome Measures

Name	Time	Method
Prevention of Hirschsprung's associated enterocolitis (HAEC)	6 months	Absence of HAEC symptoms and signs; absence of fever, abdominal distension, loose stools (diarrhea) , bloody stools during the postoperative period for 6 months.

Secondary Outcome Measures

Name	Time	Method
Improvement of stooling pattern of postoperative Hirschsprung's cases	6 months	Bowel habits and motion data are recorded at base line (start of the study) and measured throughout the study. Number of motions per day, stool consistency and periodic culture and sensitivity analysis of the stools. Improvement is measured by optimising stool output to 2-3 times daily, stool consistency according to age should be semi-solid to solids. Stool analysis improvement criteria include better consistency, absence of pus cells or red blood cells and no growth on culture for pathogenic bacteria.

Trial Locations

Locations (1)

Cairo University Pediatric Hospital; 🇪🇬 Cairo, Egypt