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.: PACTR202201686010590 Date of Approval: 04/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DIFFERENT REGIMENS FOR ERADICATION OF HELICOBACTER PYLORI INFECTION IN CHILDREN: A RANDOMIZED CONTROLLED TRIAL
Official scientific title DIFFERENT REGIMENS FOR ERADICATION OF HELICOBACTER PYLORI INFECTION IN CHILDREN: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Helicobacter pylori (H. pylori) infection is recognized as the main pathogenic factor of chronic gastritis and peptic ulcer disease in children. The prevalence of H. pylori among Egyptian school-aged children (6–15 years) ranges from 13% to 72%. The infection is usually acquired in childhood and persists lifelong in the absence of appropriate antibiotic treatment. H. pylori infection has been implicated in various gastric and extra gastric pediatric health problems. Currently, there are various diagnostic methods used for H. pylori infection which can be either invasive or non-invasive. Eradication of H. pylori infection has been associated with a reduction of the risk of chronic gastritis and recurrent peptic ulcer disease in children. Despite the progress in antimicrobial treatments, the ideal regimen for eradicating H. pylori infection has not yet been introduced. The present study was conducted to compare the efficacy, safety profile, and compliance between triple therapy, sequential therapy, hybrid therapy, concomitant therapy, and ciprofloxacin-based triple therapy as an empirical first-line therapy for the eradication of H. pylori 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
Sub-Disease(s) or condition(s) being studied Helicobacter pylori
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2022
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 Triple therapy Amoxicillin 75mg/kg/day (maximum 3g/day),, metronidazole 20 mg/kg/day (maximum 1g/day)and PPI;esomeprazole 2mg/kg/day (maximum 80mg/day) 14 days PPI (esomeprazole) will be given at least 30 minutes before meal. • All drugs will be divided in two daily doses and given orally. • Patients will be followed up weekly to check for their compliance, the side effects of medications and symptoms improvement. 40
Experimental Group sequential therapy PPI;esomeprazole 2mg/kg/day (maximum 80mg/day for 14 days with amoxicillin 75mg/kg/day (maximum 3g/day) for the first 7 days, Followed by clarithromycin 15mg/kg/day (maximum 1g/day), and metronidazole 20 mg/kg/day (maximum 1g/day) for another 7 days. 14 days PPI (esomeprazole) will be given at least 30 minutes before meal. • All drugs will be divided in two daily doses and given orally. • Patients will be followed up weekly to check for their compliance, the side effects of medications and symptoms improvement 40
Experimental Group hybrid therapy PPI;esomeprazole 2mg/kg/day (maximum 80mg/day and amoxicillin 75mg/kg/day (maximum 3g/day) for 14 days with addition of clarithromycin 15mg/kg/day (maximum 1g/day), and metronidazole 20 mg/kg/day (maximum 1g/day) for the final 7 days. 14 days PPI (esomeprazole) will be given at least 30 minutes before meal. • All drugs will be divided in two daily doses and given orally. • Patients will be followed up weekly to check for their compliance, the side effects of medications and symptoms improvement 40
Experimental Group concomitant therapy Amoxicillin 75mg/kg/day (maximum 3g/day), metronidazole 20 mg/kg/day (maximum 1g/day), clarithromycin 15mg/kg/day (maximum 1g/day)and PPI;esomeprazole2mg/kg/day (maximum 80mg/day) 14 days PPI (esomeprazole) will be given at least 30 minutes before meal. • All drugs will be divided in two daily doses and given orally. • Patients will be followed up weekly to check for their compliance, the side effects of medications and symptoms improvement 40
Control Group ciprofloxacin based triple therapy ciprofloxacin 20 mg/kg/day (maximum 1g/day, amoxicillin 75mg/kg/day (maximum 3g/day) and PPI;esomeprazole2mg/kg/day (maximum 80mg/day) 14 days PPI (esomeprazole) will be given at least 30 minutes before meal. • All drugs will be divided in two daily doses and given orally. • Patients will be followed up weekly to check for their compliance, the side effects of medications and symptoms improvement 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children suffering of symptoms suggestive of H. pylori infection. gastric biopsy positive for H pyloi infection History of drug allergy to any of the medications used in the study. Presence of any concurrent illness that prevents the intake of the eradication regimen. The intake of any previous treatment with anti-secretory, antimicrobial or anti-inflammatory medications 4 weeks prior to obtaining the gastric biopsies. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 16 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 15/07/2021 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
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 fecal H. pylori antigen four weeks after completing the treatment
Secondary Outcome Adverse effects of drugs used in the treatment four weeks after completing the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Gastroenterology Clinic and endoscopy unit at Alexandria University Childrens Hospital AUCH 40 ismael siri , ezbet saad, Sidi Gaber Alexandria 21523 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
El Said Hamdy El Sawy Khalifa 2 six street, El Nasr street, Sidi Gaber Alexandria 21523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department Alexandria University Port Said street ElShatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hind Mamdouh Hanafy Pediatric department , Alexandria University, Port Said street. El Shatby Alexandria 21526 Egypt
Sana Hosny Mohamed Barakat 10 Roshdy street, Roshdy Alexandria 21529 Egypt
Ahmed Fouad Mahmoud Khalil 45 khalil khayat street, Kafr Abdu , Sidi Gaber Alexandria 21523 Egypt
Maha Mosheer Guimei Palm Hills October Golf extension- villa 606 Giza 12566 Egypt
El Said Hamdy El Sawy Khalifa 2 six street, El Nasr street, Sidi Gaber Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hind Hanafy hind.hanafy@alexmed.edu.eg 0201222156115 Pediatric department , Alexandria University, Port Said street. El Shatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries El Said El Sawy saideinstein1@gmail.com 00201143515140 2 six street, El Nasr street, Sidi Gaber
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Assistant Lecturer of Pediatrics Faculty of Medicine Alexandria University
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
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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