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.: PACTR201708002507912 Date of Approval: 09/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of bovine colostrum in the treatment of acute diarrhea in children
Official scientific title Role of bovine colostrum in the treatment of acute diarrhea in children
Brief summary describing the background and objectives of the trial Acute infectious diarrhea is inflammation of the gastrointestinal tract that involves the stomach and small intestine. This typically lasts three to five days and less than two weeks. Gastroenteritis can be due to infections by viruses, bacteria, parasites, and fungus. The most common cause is viruses. In children, rotavirus is the most common cause of severe disease. Transmission may occur due to eating improperly prepared foods, drinking contaminated water, or through close contact with an individual who is infected. Supportive therapy(appropriate diet, fluid therapy) should be considered for all patients suffering from diarrhea, while antimicrobials are not recommended as enteropathogens are often associated with self-limiting diarrhea. Numerous in vivo and in vitro studies have shown that Bovine Colostrum (BC) is beneficial in the prevention and treatment of infective gastroenteritis. The bioactive components of colostrum include: anti-microbial factors, immune stimulating peptides and growth factors. Anti-microbial factors provide passive immunity and protect against infections, especially during the first weeks of life. The aim of the present work is to study the role of bovine colostrum (Immuguard) in the treatment of acute diarrhea in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acute diarrhea in children,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied infectious diarrhea
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2016
Actual trial start date 15/11/2016
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 05/04/2017
Anticipated target sample size (number of participants) 138
Actual target sample size (number of participants) 160
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bovine colostrum (immuguard) One sachet each of 3 gm 1 week One sachet per day for 1 week 80
Control Group Placebo One sachet each of 3 gm 1 week One sachet per day for 1 week 80 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Child with acute diarrhea Infants with history of Onset of diarrhea more than 48 hours. Infants received Prior treatment with antibiotics or antidiarrheal Infants with associated other infections and malnutrition. Infants complaining of presence of dysentery(blood,mucus in stool and tenesmus. 6 Month(s) 2 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 25/08/2016 IRB, Ethics Committee, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria, Egypt Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Disappearance of diarrhea during 1 week
Primary Outcome Disappearance of vomiting during 1 week
Secondary Outcome Disappearance of fever during 1 week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Department, El Shatby hospital, Alexandria university Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sana Hosny Mohamed Barakat 91 ahmed shawky street , moustafa kamel Alexandria 21523 Egypt
Omneya Magdy Omar 5 emarat el shorta smouha Alexandria 21641 Egypt
Doaa Ali Elbana Almosher Ahmed Esmaeel street, moustafa kamel Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sana Barakat Barakat_sana@yahoo.com 002-035443409 91 ahmed shawky street , moustafa kamel
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Omneya Omar Drmonymagdy@yahoo.com 01223768859 5 emarat el shorta smouha
City Postal code Country Position/Affiliation
Alexandria 21641 Egypt Lecture of Pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
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Changes to trial information