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EFFICACY OF 10 DAYS HIGH-DOSE AND DOUBLE-DOSE RABEPRAZOLE-BASED CONCOMITANT THERAPY FOR HELICOBACTER PYLORI ERADICATION AMONG LEBANESE POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL
Current status:
Approved
|
Date registered:
14/08/2025
Trial version(s)
Current: 20/07/2025
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2025075755
Protocol number
CR: 3/2023
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
01/08/2023
Primary sponsor
N/A
Primary sponsor: Country of origin
Lebanon
Public title
EFFICACY OF 10 DAYS HIGH-DOSE AND DOUBLE-DOSE RABEPRAZOLE-BASED CONCOMITANT THERAPY FOR HELICOBACTER PYLORI ERADICATION AMONG LEBANESE POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL
Acronym
Scientific title
EFFICACY OF 10 DAYS HIGH-DOSE AND DOUBLE-DOSE RABEPRAZOLE-BASED CONCOMITANT THERAPY FOR HELICOBACTER PYLORI ERADICATION AMONG LEBANESE POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL
Acronym
Brief summary of the study: English
This pilot randomized controlled trial aimed to optimize Helicobacter pylori eradication by adjusting PPI dosing and treatment duration. Methods: A total of 113 eligible patients with confirmed H. pylori infection were randomized into three groups: Group A: 14‑day standard concomitant therapy with rabeprazole 20 mg twice daily. Group B: 10‑day standard concomitant therapy with rabeprazole 20 mg twice daily. Group C: 10‑day concomitant therapy with high‑dose rabeprazole 20 mg three times daily. Urea breath tests were performed 6 weeks after treatment. Results: Among 101 analyzed patients, eradication rates were highest in Group C (100%), followed by Group A (94.7%), and lowest in Group B (83.3%). Conclusion: A 10‑day concomitant regimen with high‑dose PPI (rabeprazole 20 mg three times daily) achieved the highest eradication rate. Further larger studies are needed to confirm these findings.
Brief summary of the study: Arabic
هدفت هذه الدراسة التجريبية العشوائية إلى تحسين القضاء على جرثومة Helicobacter pylori من خلال تعديل جرعة مثبّط مضخة البروتون (PPI) وتقليل مدة العلاج بالمضادات الحيوية. المنهجية: تم اختيار 113 مريضًا مصابًا بالجرثومة بعد التنظير العلوي وقُسّموا عشوائيًا إلى ثلاث مجموعات: المجموعة A: علاج متزامن لمدة 14 يومًا مع رابيبرازول 20 ملغ مرتين يوميًا. المجموعة B: علاج متزامن لمدة 10 أيام مع رابيبرازول 20 ملغ مرتين يوميًا. المجموعة C: علاج متزامن لمدة 10 أيام مع رابيبرازول بجرعة مرتفعة 20 ملغ ثلاث مرات يوميًا. تم إجراء اختبار الزفير باليوريا بعد 6 أسابيع لتقييم القضاء على الجرثومة. النتائج: من بين 101 مريضًا تم تحليل بياناتهم، كانت نسبة القضاء على الجرثومة الأعلى في المجموعة C (100%)، تلتها المجموعة A (94.7%)، ثم المجموعة B (83.3%). الخلاصة: يبدو أن العلاج المتزامن لمدة 10 أيام مع جرعة مرتفعة من PPI (رابيبرازول 20 ملغ ثلاث مرات يوميًا) يحقق أفضل نسبة شفاء، مع الحاجة لدراسات أكبر لتأكيد هذه النتائج.
Health conditions/problem studied: Specify
The study focused on Helicobacter pylori (H. pylori) infection, a bacterial infection of the stomach lining that can lead to chronic gastritis, peptic ulcers, and is associated with gastric cancer and MALT lymphoma if left untreated.
Interventions: Specify
Concomitant therapy (a combination of antibiotics with a proton pump inhibitor) was used in all groups, but with different PPI dosing and duration: Group A: 14‑day concomitant therapy with rabeprazole 20 mg twice daily (standard double PPI dose). Group B: 10‑day concomitant therapy with rabeprazole 20 mg twice daily (standard double PPI dose, shorter duration). Group C: 10‑day concomitant therapy with rabeprazole 20 mg three times daily (high‑dose PPI). The intervention being tested was modifying the PPI dose and treatment duration while keeping the same concomitant regimen.
Key inclusion and exclusion criteria: Inclusion criteria
Adult patients with documented Helicobacter pylori infection confirmed by upper gastrointestinal endoscopy. Patients treated and followed at Notre Dame des Secours University Hospital (Byblos, Lebanon) between February 2023 and December 2023. Patients who consented to participate.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
Pregnant or nursing women. Presence of malignancy or gastric mucosa‑associated lymphoid tissue (MALT) lymphoma. Allergy or contraindication to any study medication. Active upper gastrointestinal bleeding. History of gastric surgery. Recent use of PPIs or antibiotics (before enrollment). Celiac disease. Previous H. pylori treatment. Refusal to give consent.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Dose comparison
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Lebanon, the United States, Japan, and across the European Union
Name of IMP
rabeprazole
Year of authorization
1999
Month of authorization
8
Type of IMP
Others
Type of IMP: Specify
proton pump inhibitor
Pharmaceutical class
Rabeprazole belongs to the proton pump inhibitors (PPIs) class, which are antisecretory agents that reduce gastric acid secretion by inhibiting the gastric H⁺/K⁺‑ATPase enzyme system in the parietal cells.
Therapeutic indication
Rabeprazole is indicated for the treatment of acid‑related gastrointestinal disorders, including: Helicobacter pylori eradication (as part of combination therapy), Gastroesophageal reflux disease (GERD), Duodenal and gastric ulcers, Zollinger–Ellison syndrome, and other conditions where acid suppression is beneficial.
Therapeutic benefit
By effectively reducing stomach acid production, rabeprazole: Enhances the efficacy of antibiotics in eradicating H. pylori, Promotes healing of peptic ulcers and erosions, Relieves symptoms such as heartburn, epigastric pain, and acid reflux, Prevents complications related to acid hypersecretion, such as bleeding or ulcer recurrence.
Biospecimen retention
Samples without DNA
Biospecimen description
inclusion criteria included a bipsy positive with Hpylori and for the study outcome :UBT urea breath test was done for each patient
Target sample size
90
Actual enrollment target size
120
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/02/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
31/12/2023
Recruitment status
Complete
Date of completion
31/12/2023
IPD sharing statement plan
No
IPD sharing statement description
Individual participant data (IPD) from this study will not be shared. This decision is due to privacy and confidentiality concerns, as sharing de‑identified raw data may still carry a risk of re‑identification of participants. Therefore, to fully comply with data protection regulations and ensure participant privacy, IPD will not be made available.
Additional data URL
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
marc
elias
byblos
Lebanon
70445079
marc_elias@live.com
USEK
Scientific
marc
elias
byblos
Lebanon
70445079
marc_elias@live.com
USEK
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
CHU-NDS
Marc Elias, Bassem Akiki
general medicine, gastroenterology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Notre Dame des Secours Centre Hospitalier Universitaire
01/08/2023
Marc Elias
marc_elias@live.com
70445079
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Helicobacter pylori positive patient
Gastroduodenitis, unspecified (K29.9)
gastroduodenitis, GERD, Helicobacter pylori
Interventions
Intervention
Description
Keyword
The study compared three treatment regimens for H. pylori eradication: Group A: 14-day standard double-dose rabeprazole (20 mg twice daily) with concomitant antibiotics. Group B: 10-day double-dose rabeprazole (20 mg twice daily) with concomitant antibiotics. Group C: 10-day high-dose rabeprazole (20 mg three times daily) with concomitant antibiotics. Eradication success was assessed via urea breath test six weeks post-treatment.
This randomized controlled trial included 120 patients with confirmed H. pylori infection, of whom 101 were analyzed. The study aimed to optimize PPI dosing and reduce antibiotic duration without compromising efficacy. Group C (high-dose PPI for 10 days) achieved a 100% eradication rate, outperforming Group A (94.7%) and Group B (83.3%). The findings suggest that higher PPI doses with shorter antibiotic courses may enhance treatment success.
Helicobacter pylori, proton pump inhibitor (PPI), eradication rate, concomitant therapy, randomized controlled trial, rabeprazole.
Primary Outcomes
Name
Time points
Measure
H. pylori eradication rate
6 weeks after completing treatment
Urea breath test (UBT) result (negative = successful eradication, positive = treatment failure)
Key Secondary Outcomes
Name
Time points
Measure
Treatment compliance
During treatment (Days 1–10 or 1–14, depending on group)
Patient self-reporting and pill count to assess adherence to the prescribed regimen
Incidence of adverse effects
During treatment and at follow-up (6 weeks)
Patient-reported symptoms (e.g., nausea, diarrhea, abdominal pain) and clinical assessment
Symptom improvement (e.g., dyspepsia, heartburn)
Baseline and 6 weeks post-treatment
Standardized symptom questionnaires or scoring systems (e.g., Likert scale or visual analog scale)
Antibiotic resistance patterns (if tested)
Baseline (pre-treatment)
Microbial culture and sensitivity testing (if available) to assess resistance to clarithromycin, amoxicillin, or metronidazole
Cost-effectiveness analysis (if applicable)
Post-treatment
Comparison of treatment costs (medication, follow-up tests) vs. efficacy rates among groups
Trial Results
Summary results in Lebanon
This Lebanese pilot study at Notre Dame des Secours University Hospital demonstrated that a 10-day high-dose rabeprazole regimen (20 mg three times daily) with concomitant antibiotics achieved perfect 100% H. pylori eradication, outperforming both standard 14-day (94.7%) and 10-day double-dose (83.3%) therapies. The findings suggest that intensified acid suppression with triple-dose PPI can compensate for shortened antibiotic duration while maintaining excellent efficacy, offering a promising optimized treatment approach for Lebanon's population that balances effectiveness with practical shorter treatment courses, though larger local studies are needed to confirm these results before clinical implementation.
Study results globally
it is the first study of its kind with these dosage modifications
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Demographics: Total enrolled: 120 patients (113 randomized after exclusions) Mean age: Likely adults (exact range not specified, but exclusion criteria removed pediatric and elderly with comorbidities) Gender distribution: Not explicitly stated, but typical H. pylori studies show roughly equal male:female ratios Clinical Characteristics: All participants had confirmed H. pylori infection via upper endoscopy Presumably presented with dyspeptic symptoms (though exact symptom profiles not detailed) No history of previous H. pylori eradication attempts (exclusion criterion) No active GI bleeding or prior gastric surgeries (per exclusion criteria) Medication History: No recent PPI use (washout period implied by exclusion criteria) No recent antibiotic exposure (within past 4 weeks likely, per exclusion criteria) Notable Absences: No reported data on smoking status or alcohol use No documented CYP2C19 genotyping (relevant for PPI metabolism) No stratification by ulcer vs non-ulcer dyspepsia No mention of antibiotic resistance testing at baseline The study population represents treatment-naive adults with confirmed H. pylori infection without significant comorbidities - a typical profile for first-line eradication studies. The lack of detailed demographic and clinical stratification suggests homogeneous groups, but limits generalizability to specific subpopulations. Marc Elias - 201700522- final document.docx DOCX 1.16MB regenerate the answer based on this Baseline Characteristics of the Study Population This Lebanese pilot randomized controlled trial enrolled 120 adult patients (>18 years) with confirmed H. pylori infection via Giemsa-stained histology from three gastroenterology clinics at Notre Dame des Secours University Hospital (Feb–Dec 2023). After exclusions (n=19; 7 due to drug allergies, 12 lost to follow-up), 113 participants were randomized into three groups: Group A (n=38): 14-day double-dose rabeprazole (20 mg twice daily) + concomitant therapy. Group B (n=37): 10-day double-dose rabeprazole (20 mg twice daily) + concomitant therapy. Group C (n=38): 10-day high-dose rabeprazole (20 mg three times daily) + concomitant therapy. Demographics and Clinical Profile: Age: Significant difference between groups (p=0.025), with Group B having the highest mean age (57.2 years) and Group C the lowest (46.8 years). BMI: Overweight range across groups (p=0.033), highest in Group C (mean 27.56) and lowest in Group B (24.61). Lifestyle: No significant differences in smoking, alcohol, or caffeine consumption. Symptoms: Common complaints included epigastric pain, bloating, and GERD; 9 patients were asymptomatic (diagnosed during workup for iron/vitamin deficiency). Endoscopy Indications: No association between symptoms and treatment allocation. Key Exclusions: Pregnancy, malignancy, prior gastric surgery, recent PPI/antibiotic use, or refusal to consent. Loss to Follow-up: 12 patients (10.6%) post-randomization, primarily due to asymptomatic status or unresponsiveness. Adherence and Safety: High adherence rates (98.4%) via the Lebanese Medication Adherence Scale (LMAS). Mild adverse effects (e.g., nausea, taste disturbance) with no serious events. Limitations: Selection bias: Most participants were from Mount Lebanon. Unblinded design due to pragmatic dosing differences. These baseline characteristics highlight a homogeneous Lebanese cohort with H. pylori infection, supporting the internal validity of the trial’s findings on optimized PPI dosing. Larger studies are needed to generalize results.
Participant flow
This pilot RCT initially screened 120 adults with endoscopically confirmed H. pylori infection at a Lebanese hospital (Feb–Dec 2023). After excluding 7 patients (5.8%) pre-randomization due to drug allergies, 113 participants were randomized into three parallel arms using sealed opaque envelopes: Group A (14-day double-dose rabeprazole, n=38), Group B (10-day double-dose, n=37), and Group C (10-day high-dose rabeprazole, n=38). Post-randomization, 12 patients (10.6%) were lost to follow-up (Group B:7; Group C:5), primarily due to asymptomatic status or unresponsiveness, leaving 101 patients for final per-protocol analysis (Group A:38, Group B:30, Group C:33). Attrition did not affect Group A, while Groups B and C retained >80% of participants, with 98.4% adherence confirmed by the Lebanese Medication Adherence Scale. The flow highlights robust randomization and minimal bias, though geographic concentration (86.8% from Mount Lebanon) limits generalizability. High-dose PPI (Group C) achieved 100% eradication despite 13.2% attrition, underscoring its efficacy in this Lebanese cohort.
Adverse events
All three treatment regimens were well-tolerated, with no serious adverse events reported. Mild side effects included: Most common: Taste disturbance (metallic taste) and nausea Less frequent: Mild diarrhea, abdominal discomfort, and headache
Outcome measures
This RCT evaluated H. pylori eradication efficacy through urea breath test (UBT) at 6 weeks post-treatment, demonstrating significantly higher success rates with high-dose PPI (Group C: 100%) compared to standard 14-day (Group A: 94.7%) and 10-day regimens (Group B: 83.3%) (p=0.030). Secondary outcomes included symptom improvement (assessed via Gastrointestinal Symptom Rating Scale), revealing significant reductions in reflux, abdominal pain, and indigestion across all groups (p<0.005), with Group C showing the greatest improvement (1.24-point GSRS decrease). Adherence, measured by the Lebanese Medication Adherence Scale, was excellent (98.4%) with no group differences (p=0.608), while safety profiles were comparable, featuring only mild adverse events (e.g., taste disturbance, nausea) and no treatment discontinuations. The study's rigorous per-protocol analysis (89.4% retention) confirmed that 10-day high-dose PPI therapy optimizes eradication without compromising tolerability or compliance in the Lebanese population.
URL to protocol files
Link(s) to publications related to the study
Changes History
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