Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Overview

Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2018

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.

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.

Arms, Groups and Cohorts

  • Active Comparator: Probiotics Group
    • Will receive Sachet-form probiotics
  • Placebo Comparator: Placebo Group
    • Will receive off-the-shelf oral multivitamin

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Hirschsprungs disease confirmed preoperative and postoperative specimen pathology Exclusion Criteria:

  • Other cases of Enterocolitis and constipation

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mahmoud Elfiky, MD, Lecturer of Pediatric Surgery – Cairo University
  • Overall Official(s)
    • Mahmoud MA Elfiky, M.D., Principal Investigator, Cairo University
  • Overall Contact(s)
    • Mahmoud MA Elfiky, M.D., +201001557755, mfiky@kasralainy.edu.eg

References

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.

Demehri, Farokh R., et al.

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