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.: PACTR202112686695509 Date of Approval: 01/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of adding nitazoxanide to the standard triple therapy in the eradication of Helicobacter pylori infection
Official scientific title Effectiveness of adding nitazoxanide to the standard triple therapy in the eradication of Helicobacter pylori infection
Brief summary describing the background and objectives of the trial H. pylori eradication definitely changes the natural history of peptic ulcer disease, in terms of recurrence and complications. Moreover, curing the infection reduces the risk of precancerous lesion evolution in the stomach. H. pylori eradication is not easily achieved, since several bacterial and host factors are involved in the therapeutic success so that an antibiotic combination is required. The aim of the study is to assess the efficacy of adding Nitazoxanide to the standard triple therapy in the eradication of H. Pylori infection
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2021
Actual trial start date 10/12/2021
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 200
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group amoxicillin based standard triple therapy 14 days will be treated with clarithromycin (Klacid , kAHIRA , Egypt ) 500mg bid, amoxicillin (E- mox , EIPICO, Egypt )1gm bid, omeprazole (Pepzol, Hikma pharmaceuticals, Egypt) 20 mg bid for 14 days 50 Active-Treatment of Control Group
Control Group Metronidazole based standard triple therapy 14 days will be treated with clarithromycin (Klacid , Kahira , Egypt ) 500mg bid, metronidazole (Flagyl, SANOFI, Egypt ) 500mg bid, omeprazole (Pepzol, Hikma pharmaceuticals, Egypt) 20 mg bid for 14 days 50 Active-Treatment of Control Group
Control Group Nitazoxanide based triple therapy 14 days will be treated with clarithromycin (Klacid , kahira, Egypt) 500mg bid, nitazoxanide (Nanazoxid, UTOPIA pharmaceuticals, Egypt) 500 mg bid , omeprazole (Pepzol, Hikma pharmaceuticals, Egypt) 20 mg bid for 14 days 50 Active-Treatment of Control Group
Experimental Group Standard triple therapy plus nitazoxanide 14 days The intervention group will be treated with clarithromycin (Klacid , kahira , Egypt ) 500mg bid, nitazoxanide (Nanazoxid, UTOPIA pharmaceuticals, Egypt) 500 mg bid, amoxicillin (E- mox, EIPICO, Egypt )1gm bid, omeprazole (Pepzol, Hikma pharmaceuticals, Egypt) 20 mg bid for 14 days 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any Naive Patient above the age of 18 years old with H.pylori infection will be included in the study. Patients infected by H.pylori will be diagnosed by stool antigen test. Patients aged less than 18 years, prior gastric surgery, Prior H. pylori eradication therapy, recent intake of antibiotics, proton pump inhibitor (PPI), histamine (H2) receptor blockers, nonsteroidal or anti-inflammatory drugs within the last month, known allergy of any of the antibiotics used in the study, gastrointestinal malignancy, active upper gastrointestinal bleeding, pregnant and lactating women will be excluded from the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,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
No 01/11/2021 Faculty of Medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
Faisal Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The eradication rate of H. pylori infection 4 weeks after completion of treatment
Secondary Outcome Side effects and noncompliance during and for 4 week after completion of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AlAzhar Assiut University Hospitl Faisal Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhammad AbdelGawad Faisal St. Assiut 71631 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No No No Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amro Hassan amrelgatet2003@gmail.com 00201013712039 Faisal
City Postal code Country Position/Affiliation
Assiut Egypt Professor of Hepatology Gastroenterology and Infectious Diseases AlAzhar University Assiut Egypt
Role Name Email Phone Street address
Public Enquiries Mohammed Fakhry mmmmmohammed642@gmail.com 00201006795783 Algalaa
City Postal code Country Position/Affiliation
Assiut Egypt Professor of gastroenterology AlAzhar Univesity Assiut Egypt
Role Name Email Phone Street address
Scientific Enquiries Muhammad AbdelGawad muhammad2013@azhar.edu.eg +201113528652 Faisal
City Postal code Country Position/Affiliation
Assiut 71631 Egypt Associate professor of Hepatology Gastroenterology and Infectious Diseases AlAzhar University Assiut Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD willl be available of request Statistical Analysis Plan,Study Protocol Within 12 months of completion of the study for one year. The IPD will be available of request by PACTR editors, Journal Editors. The data include the protocol of the study, the Statistical analysis plan, and the data collection sheet. Requests will be evaluated by authors and IPD will be sent accordingly
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