Levofloxacin-Based Sequential Therapy Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
Levofloxacin-Based Sequential Therapy Compared With Bismuth-Based Quadruple Therapy for Eradication of Helicobacter Pylori Infection: A Randomized Controlled Trial
This randomized controlled trial aims to compare the efficacy and safety of levofloxacin-based sequential therapy versus bismuth-based quadruple therapy for eradication of Helicobacter pylori infection in adult patients. Helicobacter pylori infection remains highly prevalent in developing countries and is associated with gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Increasing antibiotic resistance has reduced the effectiveness of conventional treatment regimens, creating a need for alternative first-line therapies with improved eradication rates and acceptable tolerability.
Eligible adult patients diagnosed with H. pylori infection by stool antigen testing will be recruited from the Gastroenterology Department of Services Hospital Lahore. Participants will be randomly assigned in a 1:1 ratio to receive either levofloxacin-based sequential therapy or bismuth-based quadruple therapy for 14 days.
The primary outcome of the study is successful eradication of H. pylori infection, confirmed by stool antigen testing performed 6 weeks after completion of therapy. Secondary outcomes include treatment-related adverse effects, treatment compliance, and overall treatment cost.
The study aims to identify an effective and affordable treatment strategy for H. pylori eradication in a population with high antibiotic resistance and socioeconomic limitations.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tanveer Principal Investigator
- Numéro de téléphone: 030708693386
- E-mail: tenu9428@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 20 years and older
- Confirmed Helicobacter pylori infection by stool antigen testing
- Willingness to comply with the assigned treatment regimen
- Ability to provide informed consent
- Willingness to complete follow-up evaluation
Exclusion Criteria:
- Use of antibiotics within 4 weeks prior to enrollment
- Active gastrointestinal infection other than Helicobacter pylori
- Previous gastrointestinal tract surgery
- Pregnant or lactating females
- Known allergy or intolerance to study medications
- Psychiatric illness or other condition impairing treatment compliance
- Severe comorbid illness making participation unsuitable in the investigator's judgment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Levofloxacin-Based Sequential Therapy
Participants assigned to this arm will receive levofloxacin-based sequential therapy for 14 days.
During days 1-7, participants will receive dexlansoprazole 60 mg twice daily and amoxicillin 1 g twice daily.
During days 8-14, participants will receive dexlansoprazole 60 mg twice daily, levofloxacin 500 mg once daily, and tinidazole 500 mg twice daily.
|
Participants will receive a 14-day levofloxacin-based sequential therapy regimen.
During days 1-7, participants will receive dexlansoprazole 60 mg twice daily and amoxicillin 1 g twice daily.
During days 8-14, participants will receive dexlansoprazole 60 mg twice daily, levofloxacin 500 mg once daily, and tinidazole 500 mg twice daily.
|
|
Comparateur actif: Bismuth-Based Quadruple Therapy
Participants assigned to this arm will receive bismuth-based quadruple therapy for 14 days, consisting of bismuth subsalicylate 265 mg (two tablets) twice daily, dexlansoprazole 60 mg twice daily, doxycycline (Vibramycin) 100 mg twice daily, and tinidazole 500 mg twice daily.
|
Participants will receive a 14-day bismuth-based quadruple therapy regimen consisting of bismuth subsalicylate 265 mg (two tablets) twice daily, dexlansoprazole 60 mg twice daily, doxycycline 100 mg twice daily, and tinidazole 500 mg twice daily.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Helicobacter pylori Eradication Rate
Délai: 6 weeks after completion of therapy
|
6 weeks after completion of therapy
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 156
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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