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Trial details
Trial details
Comparison of Two Treatment Regimens for Helicobacter pylori Eradication in Lebanon
Current status:
Approved
|
Date registered:
17/10/2024
Trial version(s)
Current: 16/09/2024
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2024095653
Protocol number
H.pylori-2016-001
MOH registration number
NA
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
The trial is being registered retrospectively to ensure transparency and contribute to scientific knowledge, as initial efforts focused on ethical approvals and study implementation.
Date of registration in national regulatory agency
Primary sponsor
Holy Spirit University of Kaslik (USEK), School of Medicine and Medical Sciences.
Primary sponsor: Country of origin
Lebanon
Public title
Comparison of Two Treatment Regimens for Helicobacter pylori Eradication in Lebanon
Acronym
CTBQT-H. pylori
Scientific title
A Randomized Prospective and Crossover Study Comparing the Eradication Rate After 10 Days of Concomitant Therapy to Bismuth Quadruple Therapy Among a Sample of the Lebanese Population
Acronym
RCT-COMP-BQT
Brief summary of the study: English
This study aimed to compare the effectiveness of two treatment regimens, concomitant therapy and bismuth quadruple therapy, for the eradication of *Helicobacter pylori* among a sample of the Lebanese population. It was a randomized, prospective, and crossover study conducted between 2016 and 2018. Patients with active *H. pylori* infection were divided into two groups and treated with either regimen for 10 days. The eradication success was assessed using the 14C urea breath test. Both therapies were found to be equally effective as first-line treatments, but concomitant therapy showed higher efficacy when used as a second-line treatment.
Brief summary of the study: Arabic
تهدف هذه الدراسة إلى مقارنة فعالية نظامي علاج، العلاج المتزامن والعلاج الرباعي المحتوي على البزموت، في استئصال جرثومة *Helicobacter pylori* بين عينة من السكان اللبنانيين. كانت الدراسة عشوائية، استباقية، ومتقاطعة أُجريت بين عامي 2016 و2018. تم تقسيم المرضى المصابين بعدوى *H. pylori* النشطة إلى مجموعتين وتلقوا أحد النظامين العلاجيين لمدة 10 أيام. تم تقييم نجاح الاستئصال باستخدام اختبار التنفس باليوريا 14C. أظهرت النتائج أن كلا النظامين كانا فعالين بالتساوي كعلاج أولي، بينما أظهر العلاج المتزامن فعالية أعلى عند استخدامه كعلاج ثانٍ.
Health conditions/problem studied: Specify
The health condition/problem studied in this trial is **Helicobacter pylori infection**, which is associated with gastrointestinal disorders such as gastritis, peptic ulcers, and an increased risk of gastric cancer and MALT lymphoma.
Interventions: Specify
The interventions in the study were two treatment regimens for the eradication of *Helicobacter pylori*: 1. **Concomitant Therapy**: A 10-day regimen consisting of esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily. 2. **Bismuth Quadruple Therapy**: A 10-day regimen consisting of esomeprazole 40 mg twice daily, along with a capsule containing bismuth, tetracycline, and metronidazole (3 capsules taken four times a day). Patients who did not achieve eradication with the first treatment were switched to the other therapy.
Key inclusion and exclusion criteria: Inclusion criteria
The inclusion criteria for the study were: 1. **Positive Helicobacter pylori infection** confirmed through histological findings. 2. **No prior eradication therapy** for *Helicobacter pylori*. 3. **Written informed consent** provided by all participants. These criteria ensured that the study focused on patients with active *H. pylori* infections who had not undergone previous treatment.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
75
Key inclusion and exclusion criteria: Exclusion criteria
The exclusion criteria for the study were as follows: 1. **Recent exposure to antibiotics**. 2. **History of allergy or intolerance** to any of the components in the treatment regimens. 3. **Presence of gastric cancer** confirmed by histological findings. 4. **Patients who had undergone prior eradication therapy** for *Helicobacter pylori*. These criteria ensured the exclusion of patients who might have confounding factors affecting treatment outcomes or safety.
Type of Study
Type
Observational
Study model
Case-Crossover
Study model: Explain model
It included a crossover component, where patients who did not respond to the initial treatment were switched to the alternative therapy and re-evaluated.
Time perspective
Prospective
Time perspective: Explain time perspective
It was prospective, meaning data were collected as the study progressed.
Target follow-up duration
6
Target follow-up duration: Unit
weeks
Number of groups/cohorts
2
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
427
Actual enrollment target size
374
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/03/2016
Date of study closure: Type
Actual
Date of study closure: Date
01/12/2018
Recruitment status
Complete
Date of completion
31/12/2018
IPD sharing statement plan
No
IPD sharing statement description
NA
Additional data URL
NA
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Jad
Chidiac
Paris
France
0763918897
jad_chidiac@live.com
USEK
Scientific
Charbel
Yazbeck
Jbeil
Lebanon
03334998
charbelyazbeck@usek.edu.lb@live.com
USEK
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
Primary Outcomes
Name
Time points
Measure
Key Secondary Outcomes
Name
Time points
Measure
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial