An Interventional Trial to Assess the Efficacy of Probiotics for Helicobacter pylori Infection

Development and Efficacy Assessment of Novel Probiotic Food for the Helicobacter pylori Infection - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091545

Enrollment

Registered

2025-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K290- Acute gastritis

Interventions

Intervention1: Randomized, double-blind, parallel-group trial: This randomized, double-blind, parallel-group trial will evaluate an adjunctive probiotic therapy for Helicobacter pylori infection. Sixt

Eligibility

Inclusion criteria

Inclusion criteria: Participants must be between 18 and 65 years of age, inclusive, Diagnosis of Helicobacter pylori infection confirmed by a positive Rapid Urease Test (RUT) or histological findings from endoscopic biopsy suggestive of H. pylori presence, Both male and female participants are eligible for inclusion.

Exclusion criteria

Exclusion criteria: Current or recent (within 45 days) antibiotic therapy, Presence of any co-existing chronic gastrointestinal (GI) disorder or significant hepatic, renal, or cardiac disease, Diagnosis of any form of cancer,Concurrent use of medications known to interfere with H. pylori eradication regimens or otherwise affect the gastrointestinal system, History of prior gastrointestinal surgery, Women who are pregnant or breastfeeding, Ongoing use of hormonal drugs, Current use of proton pump inhibitors (PPIs), H2-receptor antagonists, antibiotics, or probiotic supplements, 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 co-primary endpoints, assessed at Day 45, are the rate of H. pylori eradication, confirmed by post-treatment endoscopic and histological evaluation, and the clinical-inflammatory response. This response is measured by the change from baseline in the GSRS, CBC, and CRP levels. The study will compare these outcomes between the group receiving probiotics and the control group.Timepoint: Pre-recruitment Phase	—

Measure

Time frame

The primary objective is to determine the efficacy of an adjunctive probiotic regimen for Helicobacter pylori infection. The co-primary endpoints, assessed at Day 45, are the rate of H. pylori eradication, confirmed by post-treatment endoscopic and histological evaluation, and the clinical-inflammatory response. This response is measured by the change from baseline in the GSRS, CBC, and CRP levels. The study will compare these outcomes between the group receiving probiotics and the control group.Timepoint: Pre-recruitment Phase

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Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactVidhi Shah

Gujarat University

vidhishah@gujaratuniversity.ac.in7600668601

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026