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.: PACTR202304859303467 Date of Approval: 24/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of Probiotics in Helicobacter pylori (H. Pylori) Eradication?
Official scientific title Can Probiotics Play a Role in Helicobacter pylori (H. Pylori) Eradication?
Brief summary describing the background and objectives of the trial H. Pylori is one of the commonest infectious diseases worldwide. In recent years, PPI-based triple therapy has been described to be losing its efficacy against H. pylori due to high rates of antibiotic resistance, antibiotics-associated side effects, and low compliance. Probiotics are suggested to improve H. pylori eradication rate when added to H pylori therapy. Probiotics have anti-inflammatory and anti-oxidative mechanisms that may improve bowel microecology and interact with the microbial flora of the gastrointestinal tract to produce a beneficial effect in H Pylori eradication. Probiotics may be also responsible for the reduction of the adverse effects related to H. pylori therapy that may result in treatment failure. Aim of the work: In our study, we assessed the role of probiotics in improving H. Pylori eradication rate and reducing side effects after antibiotic-based therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Helicobacter Pylori
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 01/12/2021
Actual Last follow-up date 01/10/2022
Anticipated target sample size (number of participants) 159
Actual target sample size (number of participants) 150
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard therpy group Proton Pump inhibitor (Omeprazole 40 mg bid), amoxicillin (1000 mg bid), and clarithromycin (500 mg bid) 4 weeks Two weeks of triple therapy (Standard therapy) comprising Proton Pump inhibitor (Omeprazole 40 mg bid), amoxicillin (1000 mg bid), and clarithromycin (500 mg bid), followed by 2 weeks of placebo in the form of yogurt not containing probiotic. 50 Active-Treatment of Control Group
Experimental Group Study group Two weeks of triple therapy (Standard therapy) comprising Proton Pump inhibitor (Omeprazole 40 mg bid), amoxicillin (1000 mg bid), and clarithromycin (500 mg bid), followed by 2 weeks of probiotics (yogurt containing probiotics). Patients were randomly selected to receive probiotics either before or after the standard therapy. 4 weeks Two weeks of triple therapy (Standard therapy) comprising Proton Pump inhibitor (Omeprazole 40 mg bid), amoxicillin (1000 mg bid), and clarithromycin (500 mg bid), followed by 2 weeks of probiotics (yogurt containing probiotics). Patients were randomly selected to receive probiotics either before or after the standard therapy. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Symptomatic patients who were positive H Pylori stool antigen and had never been treated for H.Pylori. Patients below 18 years or above 80 years of age previously received H. pylori eradication therapy use of antimicrobials or medications that might interfere with H Pylori stool antigen detection( like PPI or H2 blockers use within the previous 2 weeks of stool testing) previous incidents of gastric or duodenal bleeding, gastric surgery, gastric malignancy, or other life-threatening conditions unwilling to give consent. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 02/10/2018 Theodor Bilharz Research Institute Ethical Comitte
Ethics Committee Address
Street address City Postal code Country
Kornish Elneel, Warak Elhadar GIZA Imbaba 30 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To study the impact of adding probiotics to standard triple therapy for achieving better H. pylori eradication rates compared to standard triple therapy alone. Four weeks after therapy
Secondary Outcome To assess the role of probiotics in the correction of gut dysbiosis after eradication therapy To study the side effects of antibiotics in the probiotics receiving group versus the other group To assess obesity as a variant factor that might affect the acquisition of H Pylori infection, response to standard triple therapy and effect of adding probiotics to modify treatment response 4 weeks after therpy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Theodor Bilharz Research Institute Kornish El-Nile, Warak Elhadar Giza 12411 Egypt
Nationa Reasearch Centre 33 Elbuhoth Street GIZA 12622 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Theodor Bilharz research Institute Kornish Elneel Warak Elhadar GIZA Imbaba 30 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Theodor BIlharz REasearch Institute Kornish Elneel Warak Elhadar GIZA Imbaba 30 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
National Research Centre Albouhouth Doky GIZA 12622 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Fakhry smfakhry@hotmail.com +201223102173 Theodor Bilharz Research Institute, Kornish El-Nile, Warak El-Hadar
City Postal code Country Position/Affiliation
Giza Imbaba 30 Egypt Professor of Tropical Medicine TBRI
Role Name Email Phone Street address
Scientific Enquiries Mohamed Kandyl drmkandyl84@gmail.com +201114886247 TBRI Wark Elhadar
City Postal code Country Position/Affiliation
GIZA Imbaba 30 Egypt Researcher of Gasteroenterology and hepatology TBRI
Role Name Email Phone Street address
Scientific Enquiries Nayra Mehanna mehanna2006@hotmail.com +201005640010 National Reasearch Centre 33 Elbuhouth St Dokki
City Postal code Country Position/Affiliation
Giza 12622 Egypt Prof of Food and dairy microbiology Head of probiotics Lab Central Laboratories Network National Research Center
Role Name Email Phone Street address
Scientific Enquiries Adel Hashish af.hashish@nrc.sci.eg +201008550294 National Reasearch Centre 33 Elbuhouth St Dokki
City Postal code Country Position/Affiliation
GIZA 12622 Egypt Professor of Medical Biochemistry Head of children with special needs NRC
Role Name Email Phone Street address
Scientific Enquiries Wafaa Kandeel wafakandeel@yahoo.com +201222400488 National Reasearch Centre 33 Elbuhouth St Dokki giza
City Postal code Country Position/Affiliation
giza 12622 Egypt Prof Biological Anthropology biological Anthropology Department NRC
Role Name Email Phone Street address
Scientific Enquiries Hoda ElSayed drhodasamir@yaho.com +201111266427 National Reasearch Centre 33 Elbuhouth St Dokki
City Postal code Country Position/Affiliation
GIZA 126222 Egypt Researcher of Dairy and Food Microbiology NRC
Role Name Email Phone Street address
Scientific Enquiries Ahmed ElShenawy ahm_mos79@hotmail.com +201225777895 Theodor Bilharz Research Institute, Kornish El-Nile, Warak El-Hadar,
City Postal code Country Position/Affiliation
GIZA Imbab 30 Egypt Researcher Microbiology department TBRI.
Role Name Email Phone Street address
Principal Investigator Sameh Badr dr.same.badr@gmail.com +201061007584 Theodor Bilharz Research Institute, Kornish El-Nile, Warak El-Hadar, Imbaba
City Postal code Country Position/Affiliation
GIZA Imbaba 30 Egypt Assistant researcher Hepatology and gastroenterology TBRI
Role Name Email Phone Street address
Public Enquiries Mohamed Dewidar Drmohameddewidar1989@gmail.com +01016076055 Theodor Bilharz Research Institute, Kornish El-Nile, Warak El-Hadar, Imbaba
City Postal code Country Position/Affiliation
GIZA Imbaba 30 Egypt Assistant Researcher Hepatology and gastroenterology TBRI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, I will share IPD, all of the individual participant data were collected during the trial, after deidentification. Other documents will be available, Study Protocol. For researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to drmkandyl84@gmail.com. Data will be available for 2 years after publication. Study Protocol Data will be made accessible for up to 24 months. The extension will be considered on a case-by-case basis Helicobacter pylori, Eradication therapy, Probiotics, Diarrhea after antibiotics therapy
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 25/03/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/03/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/03/2023 More clear ethics approval letter TRUE, Theodor Bilharz Research Institute Ethical Comitte, Kornish Elneel, Warak Elhadar, GIZA, Imbaba 30, Egypt, , 02 Oct 2018, +235401019, tbripersidentoffice@gmail.com, 25434_24260_4737.pdf TRUE, Theodor Bilharz Research Institute Ethical Comitte, Kornish Elneel, Warak Elhadar, GIZA, Imbaba 30, Egypt, , 02 Oct 2018, +235401019, tbripersidentoffice@gmail.com, 25434_24260_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 27/03/2023 Statement about the intended sharing of de-identified individual trial participant data Data requests can be submitted starting after article publication and the data will be made accessible for up to 24 months. The extension will be considered on a case-by-case basis Yes, all of the individual participant data were collected during the trial, after deidentification. Other documents will be available, Study Protocol. For researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to drmkandyl84@gmail.com. Data will be available for 2 years after publication.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 27/03/2023 Statement about the intended sharing of de-identified individual trial participant data Yes, all of the individual participant data were collected during the trial, after deidentification. Other documents will be available, Study Protocol. For researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to drmkandyl84@gmail.com. Data will be available for 2 years after publication. Yes, I will share IPD, all of the individual participant data were collected during the trial, after deidentification. Other documents will be available, Study Protocol. For researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to drmkandyl84@gmail.com. Data will be available for 2 years after publication.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 27/03/2023 No change 01 Jan 0001
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 27/03/2023 No change 01 Jan 0001