Confirmed Helicobacter pylori infection in adults aged 18 to 65 years Helicobacter pylori infection Helicobacter pylori eradication quadruple therapy probiotics Lactobacillus reuteri stool antigen test randomized controlled trial dyspepsia bismuth-based therapy gastrointestinal adverse effects
Conditions
Interventions
Bismuth based quadruple therapy consisting of omeprazole 40 mg twice daily, bismuth subsalicylate 262 mg 2 tablets four times daily, doxycycline 100 mg twice daily, and metronidazole 400 mg three time
Experimental Drug,Active Comparator Drug
Bismuth based quadruple therapy plus Lactobacillus reuteri probiotic supplementation,Bismuth based quadruple therapy
Sponsors
Khawaja Muhammad Safdar Medical College Sialkot
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 Diagnosed with H. pylori infection confirmed by a positive stool antigen test, 2 No history of prior H. pylori eradication therapy, 3 Willingness to participate and provide written informed consent
Exclusion criteria
Exclusion criteria: 1 Known allergy or hypersensitivity to quadruple therapy components (proton pump inhibitor, doxycycline, bismuth subsalisylate, metronidazole) or the probiotic supplement. 2 Use of probiotics or antibiotics within four weeks before study enrollment. 3 Pregnancy or breastfeeding. 4 Severe comorbidity such as advanced cardiovascular, renal, hepatic, or respiratory diseases, malignancy, or immunosuppression. 5 Regular NSAID use or complications like active bleeding ulcers or perforation. 6 History of prior gastrointestinal surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication 2 weeks after end of the intervention Stool antigen test for Helicobacter pylori using enzyme linked immunosorbent assay ELISA, interpreted as positive or negative based on manufacturer defined cutoff values | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of treatment related adverse effects during therapy and 1 week post treatment Structured questionnaire for assessment of treatment related adverse effects including nausea, diarrhea, bloating, taste disturbance, and epigastric pain | — |
Countries
Pakistan
Contacts
Public ContactAtif Arif
KMSMC, Sialkot
Outcome results
None listed