Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201408000867421 Date of Approval: 12/08/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Probiotics for Prophylaxis of postoperative Hirschsprungs Associated Enterocolitis
Official scientific title Probiotics for Prophylaxis of postoperative Hirschsprungs Associated Enterocolitis
Brief summary describing the background and objectives of the trial Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Hirschsprung,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 28/02/2015
Actual Last follow-up date 28/02/2015
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Probiotics daily 3 Months Sachet 15
Control Group None none none none 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hirschsprungs disease confirmed preoperative and postoperative specimen pathology Other cases of Enterocolitis and constipation 6 Month(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2014 Surgery Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy, Faculty of Medicine Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevention of Enterocolitis No symptoms of HAEC Stool culture
Secondary Outcome Improvement of bowel motions & content Improvement of bowel habits Stool analysis parameters normalised
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Pediatric Hospital 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Pediatric Hospital 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cairo University Pediatric Hospital 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim St., kasralainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer of Pediatric Surgery
Role Name Email Phone Street address
Public Enquiries Mostafa Gad mostafagad@kasralainy.edu.eg 201002265009 1 Ali Ibrahim St., kasralainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assitant Lecturer of Pediatric Surgery
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim St., kasralainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer of Pediatric Surgery
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information