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.: PACTR201807134057681 Date of Approval: 26/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Helicobacter pylori eradication in children
Official scientific title Comparative study of efficacy of dual therapy with amoxicillin/omeprazole to the standard triple therapy in eradication of Helicobacter pylori infection in children
Brief summary describing the background and objectives of the trial H. pylori is the most common bacterial infection in humans affecting approximately 50 % of the world’s population being more common in developing countries. To eradicate Helicobacter pylori infection, the globally accepted standard regimen is a triple therapy using a proton pump inhibitor (PPI) and two antibiotics, such as clarithromycin and amoxicillin or metronidazole. However, eradication rates with triple therapy have fallen below 80% owing to increasing prevalence of clarithromycin resistance. Given this development, a dual therapy with amoxicillin and a PPI, without clarithromycin, could provide an alternative regimen if the eradication rate is acceptable. The objective of this study is to compare a three times daily dual therapy using omeprazole and amoxicillin, with the standard triple therapy using omeprazole, amoxicillin and metronidazole for effectiveness in H. pylori eradication in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Helicobacter pylori gastritis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/07/2019
Anticipated target sample size (number of participants) 156
Actual target sample size (number of participants) 156
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dual therapy Amoxicillin(50 mg/kg/day) and Omeprazole (3 mg/kg/day) 2 weeks Three times daily ,before meals with one hour 78
Control Group Triple therapy Amoxicillin (50mg/kg/day), Metronidazole(20mg/kg/day) and Omeprazole(1mg/kg/day) 2 weeks Twice daily, before meals with one hour 78 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Endoscopic biopsy based diagnosis of H. pylori gastritis in patients having upper gastrointestinal symptoms suggestive of peptic ulcer disease. Previous treatment with antisecretory, antimicrobial or anti-inflammatory medication, for 3 weeks preceding the endoscopy. History of drug allergy to any of medications used in the study. Presence of any concurrent illness that prevents intake of medication. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 14 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 16/02/2017 Ethics Committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Eradication of H. pylori (by H. pylori stool antigen test) 4 weeks from start of therapy.
Secondary Outcome Adverse effects of therapy(headache, upper respiratory tract infection, diarrhea, nausea and abdominal discomfort) After 1 week from start of therapy and at the end of therapy
Secondary Outcome Compliance After 1 week from start of therapy and at the end of therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric department Faculty of medicine Alexandria University Portsaid st, EL Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department Faculty of medicine Alexandria university 17 Champollion Street, El Messalah Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sana Barkat 22 El-Shatby Alexandria University Childrens Hospital Qesm Bab Sharqi Alexandria 21521 Egypt
Saba Elgendi 1 El-Khartom Square Faculty of medicine University of Alexandria Alexandria 21521 Egypt
Amal Mahfouz 22 El-Shatby Alexandria University Childrens Hospital Qesm Bab Sharqi Alexandria 21521 Egypt
Abeer Mohamed Sherif 65 Elfakhrany street Gamal Abd Elnasser Sidi bishr Alexandria 21624 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sana Barakat Barakat_sana@yahoo.com 00201152463632 22 El-Shatby Alexandria University Childrens HospitalQesm Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor at pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Saba Elgendi sabaelgendi@yahoo.com 00201224446260 1 El-Khartom Square Faculty of Medicine University of Alexandria
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Assistant Professor of Pathology Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information