Clinical Trial: Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

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 Summary: 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.
Sponsor: Cairo University

Current Primary Outcome: Prevention of Hirschsprung's associated enterocolitis (HAEC) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement of stooling pattern of postoperative Hirschsprung's cases [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: January 9, 2015
Date Started: October 2014
Date Completion: December 2016
Last Updated: August 16, 2016
Last Verified: August 2016