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Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Primary Purpose

Hirschsprung Disease

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Probiotics

Placebo

About this trial

This is an interventional prevention trial for Hirschsprung Disease

Eligibility Criteria

6 Months - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria:

Other cases of Enterocolitis and constipation

Sites / Locations

Cairo University Pediatric HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics Group

Placebo Group

Arm Description

Will receive Sachet-form probiotics

Will receive off-the-shelf oral multivitamin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02343562

First Posted

January 9, 2015

Last Updated

January 27, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02343562

Brief Title

Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Official Title

Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hirschsprung Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Probiotic Sachets

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

Probiotic Sachets

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotics Group

Arm Type

Active Comparator

Arm Description

Will receive Sachet-form probiotics

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Will receive off-the-shelf oral multivitamin

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotics

Other Intervention Name(s)

Lacteol Forte

Intervention Description

Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Multisanostol

Intervention Description

Multivitamin off-the-counter.

Primary Outcome Measure Information:

Title

Prevention of Hirschsprung's associated enterocolitis (HAEC)

Description

Absence of HAEC symptoms and signs; absence of fever, abdominal distension, loose stools (diarrhea) , bloody stools during the postoperative period for 6 months.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Improvement of stooling pattern of postoperative Hirschsprung's cases

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hirschsprungs disease confirmed preoperative and postoperative specimen pathology Exclusion Criteria: Other cases of Enterocolitis and constipation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mahmoud MA Elfiky, M.D.

Phone

+201001557755

mfiky@kasralainy.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa A Gad

Phone

+201002265009

mostafagad@kasralainy.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud MA Elfiky, M.D.

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo University Pediatric Hospital

City

Cairo

ZIP/Postal Code

11432

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahmoud Elfiky, MD

mfiky@kasralainy.edu.eg

First Name & Middle Initial & Last Name & Degree

Mostafa Gad, MD

mostafagad@kasralainy.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

23331802

Citation

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.

Results Reference

background

Citation

Demehri, Farokh R., et al.

Results Reference

background

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Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

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