Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Hirschsprung Disease Clinical Trial

Official title:

Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02343562
• Other study ID #: CAIUNIPEDSURG-CR1
• Secondary ID: PACTR20140800086
• Status: Recruiting
• Phase: Phase 4
• First received: January 9, 2015
• Last updated: January 27, 2018
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Mahmoud MA Elfiky, M.D.
• Phone: +201001557755
• Email: mfiky[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria:

• Other cases of Enterocolitis and constipation

Related Conditions & MeSH terms

• Enterocolitis
• Hirschsprung Disease

Intervention

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.
• Placebo
Multivitamin off-the-counter.

Locations

Country	Name	City	State
Egypt	Cairo University Pediatric Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Demehri, Farokh R., et al.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of stooling pattern of postoperative Hirschsprung's cases	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.	6 months