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.: PACTR202212783625379 Date of Approval: 12/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Helicobacter Pylori Eradication on Hepatic Steatosis of Children with Non-Alcoholic Fatty Liver Disease and Attending Alexandria University Children’s Hospital
Official scientific title Effect of Helicobacter Pylori Eradication on Hepatic Steatosis of Children with Non-Alcoholic Fatty Liver Disease and Attending Alexandria University Children’s Hospital
Brief summary describing the background and objectives of the trial Non-alcoholic fatty liver disease is considered one of the most common causes of liver disease in children due to increased prevalence of obesity worldwide. It is closely associated to metabolic syndrome. It's prevalence among children and adolescents in Egypt reaches 15.8%. Helicobacter pylori is a gram-negative bacterium in close relationship with gut microbiota. Its prevalence in asymptomatic Egyptian children ranging from 18 to 41% versus 64% in symptomatic children in Egypt. There is an evidence supporting association of helicobacter pylori infection with non-alcoholic fatty liver disease . Helicobacter pylori penetration in the gastrointestinal epithelium increases its permeability, thus, allowing gut microbiota and their metabolites translocation into portal circulation, activation of inflammation in hepatocytes and thus, progression of non-alcoholic fatty liver disease. Helicobacter pylori invasion and stay in hepatocytes is dependent on cytotoxin-associated gene A, vacuolating cytotoxin A or blood-antigen binding protein A adhesion status. To date, no clear answer to the questions regarding the association between helicobacter pylori infection and the progression of non-alcoholic fatty liver disease in children and eradication of helicobacter pylori can help in reducing hepatic steatosis or not. The aim of the present work is to assess the efficacy of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile and homeostatic model assessment of insulin resistance in children with non-alcoholic fatty liver disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/12/2022
Actual trial start date
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Concomitant therapy (Doses will be calculated based on weight) Proton pump inhibitor(15–24 kg…20mg twice daily 25–34 kg….30mg twice daily >35kg…40mg twice daily) Amoxicillin (15–24 kg…500mg twice daily 25–34 kg….750mg twice daily >35kg…1000mgtwice daily) Clarithromycin (15–24 kg…250mg twice daily 25–34 kg….500mg morning dose and 250 mg evening dose >35kg…500mg twice daily) Metronidazole (15–24 kg…250mg twice daily 25–34 kg….500mg morning dose and 250 mg evening dose >35kg…500mg twice daily) life style modifications ( consumption of healthy well balanced diet,avoidance of sugar- sweetened beverages, moderate exercise daily,less than two hour per day screen time) Proton pump inhibitor (twice daily for one month) Antibiotics(twice Daily for two weeks) life style modifications (daily) Doses will be admitted as described 25
Control Group Conventional treatment of fatty liver life style modifications N/A daily till end of the study Consumption of healthy well balanced diet,avoidance of sugar- sweetened beverages, moderate exercise daily,less than two hour per day screen time 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children meeting ultrasonic criteria of Non-alcoholic fatty liver disease . Children with fatty liver disease due to other causes rather than Non-alcoholic fatty liver disease (e.g., viral hepatitis, celiac disease, metabolic liver diseases) are excluded Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 18 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 17/11/2022 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, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fatty liver index Before and after six months of treatment
Primary Outcome Hepatic steatosis index Before and after six months of treatment
Primary Outcome NAFLD liver fat score Before and after six months of treatment
Secondary Outcome Body mass index Before and after six months of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hepatology clinic of Alexandria University Childrens Hospital 40 Ismail Sari Ezbet Saad Sidi Gaber Alexandria 41554 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Basant Samir Abdelazim Abdelhamid New King street King marriott Alexandria 23713 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Pediatrics Faculty of Medicine Alexandria University PortSaid Street Shatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sana Hosny Mohamed Barakat 10 Roshdy street Alexandria 21529 Egypt
Mohamed AbdelFadeel Youssef Ragab 29 Fawzy Moaaz street, Smouha Alexandria 31233 Egypt
Ola Atef Mohamed Sharaki Albert Al Awal street, Smouha Alexandria 21648 Egypt
Amel Ahmed Ali Mahfouz 10 Fayroza street, Smouha Sidi Gaber Alexandria 21523 Egypt
Mohamed Mahmoud Elshafei 277 abd elaziz fahmy street, stanly Alexandria 21563 Egypt
Basant Samir Abdelazim Abdelhamid New King street, King marriott Alexandria 23713 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sana Barakat barakat_sana@yahoo.com 00201152463632 10 Roshdy street
City Postal code Country Position/Affiliation
Alexandria 21529 Egypt Professor of Pediatric Faculty of Medicine Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Amel Mahfouz amelaly2006@yahoo.com 00201224007832 10 Fayroza street, Smouha Sidi Gaber
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Assistant Professor of Pediatric Faculty of Medicine Alexandria University Egypt
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 Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available immediately following publication. No end date. Data will be available for anyone who wishes to access the data Data will be available for any type (purpose) of analysis Proposals should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com 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