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Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343562
Recruitment Status : Unknown
Verified January 2018 by Mahmoud Elfiky, MD, Cairo University.
Recruitment status was:  Recruiting
First Posted : January 22, 2015
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mahmoud Elfiky, MD, Cairo University

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.

Condition or disease Intervention/treatment Phase
Hirschsprung Disease Dietary Supplement: Probiotics Dietary Supplement: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Probiotic Sachets
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Probiotic Sachets
Primary Purpose: Prevention
Official Title: Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Probiotics Group
Will receive Sachet-form probiotics
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.
Other Name: Lacteol Forte

Placebo Comparator: Placebo Group
Will receive off-the-shelf oral multivitamin
Dietary Supplement: Placebo
Multivitamin off-the-counter.
Other Name: Multisanostol




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria:

  • Other cases of Enterocolitis and constipation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343562


Contacts
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Contact: Mahmoud MA Elfiky, M.D. +201001557755 mfiky@kasralainy.edu.eg
Contact: Mostafa A Gad +201002265009 mostafagad@kasralainy.edu.eg

Locations
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Egypt
Cairo University Pediatric Hospital Recruiting
Cairo, Egypt, 11432
Contact: Mahmoud Elfiky, MD       mfiky@kasralainy.edu.eg   
Contact: Mostafa Gad, MD       mostafagad@kasralainy.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mahmoud MA Elfiky, M.D. Cairo University

Publications:
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Responsible Party: Mahmoud Elfiky, MD, Lecturer of Pediatric Surgery, Cairo University
ClinicalTrials.gov Identifier: NCT02343562    
Other Study ID Numbers: CAIUNIPEDSURG-CR1
PACTR201408000867421 ( Other Identifier: PACTR )
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Enterocolitis
Hirschsprung Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Digestive System Abnormalities
Megacolon
Colonic Diseases
Congenital Abnormalities