Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

NCT ID: NCT02343562

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Hirschsprung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Probiotic Sachets
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Probiotic Sachets

Study Groups

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Probiotics Group

Will receive Sachet-form probiotics

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Group

Will receive off-the-shelf oral multivitamin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Multivitamin off-the-counter.

Interventions

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Probiotics

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

Placebo

Multivitamin off-the-counter.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lacteol Forte Multisanostol

Eligibility Criteria

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Inclusion Criteria

* Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria

* Other cases of Enterocolitis and constipation
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Elfiky, MD

Lecturer of Pediatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud MA Elfiky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University Pediatric Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud MA Elfiky, M.D.

Role: CONTACT

+201001557755

Mostafa A Gad

Role: CONTACT

+201002265009

Facility Contacts

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Mahmoud Elfiky, MD

Role: primary

Mostafa Gad, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 23331802 (View on PubMed)

Demehri, Farokh R., et al.

Reference Type BACKGROUND

Other Identifiers

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PACTR201408000867421

Identifier Type: OTHER

Identifier Source: secondary_id

CAIUNIPEDSURG-CR1

Identifier Type: -

Identifier Source: org_study_id

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