Health Condition 1: K29- Gastritis and duodenitis
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Department of Life Sciences, Food Science and Nutrition, Gujarat University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be between 18 and 65 years of age, inclusive. 2. Diagnosis of Helicobacter pylori infection confirmed by a positive Rapid Urease Test (RUT) or histological findings from endoscopic biopsy suggestive of H. pylori presence. 3. Both male and female participants are eligible for inclusion. 4. Patients will have a similar type of antibiotic and PPI therapy throughout the study.
Exclusion criteria
Exclusion criteria: 1. Current or recent (within 45 days) antibiotic therapy. 2. Presence of any co-existing chronic gastrointestinal (GI) disorder, or significant hepatic, renal, or cardiac disease. 3. Diagnosis of any form of cancer. 4. Current use of proton pump inhibitors (PPIs), H2-receptor antagonists, antibiotics, probiotic supplements or medications known to interfere with H. pylori eradication regimen. 5. History of prior gastrointestinal surgery. 6. Women who are pregnant or breastfeeding. 7. Ongoing use of hormonal drugs. 8. Known allergy or hypersensitivity to any of the antibiotics planned for use in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the efficacy of an adjunctive probiotic regimen for Helicobacter pylori infection. The primary endpoints, assessed at Day 0 and Day 61, by RUT(on 0th day), GSRS, CBC, CRP and stool antigent test (on 61st day). The study will compare these outcomes between the group receiving standard antibiotics and PPI treatment along with a probiotic capsule for 60 days and the control group which receive only standard antibiotics and PPI treatment.Timepoint: At baseline (0th day) and at 61st day | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactVidhi Shah
Gujarat University
Outcome results
None listed