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Efficacy of bismuth quadruple therapy with bacillus clausii UBBC-07 and zinc carnosine for helicobacter pylori eradication: a double blind, parallel arm, randomized controlled trial

Efficacy of bismuth quadruple therapy with bacillus clausii UBBC-07 and zinc carnosine for helicobacter pylori eradication: a double blind, parallel arm, randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102363
Enrollment
170
Registered
2026-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K293- Chronic superficial gastritis Health Condition 2: K30- Functional dyspepsia Health Condition 3: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Interventions

Intervention1: Nil: Nil Intervention2: Bacillus clausii UBBC-07 and zinc carnosine (a chelated compound composed of 77% of L-carnosine and 23% of elemental zinc): The investigational product a combina

Sponsors

Unique Biotech Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients tested positive for H. pylori on endoscopy by either RUT or HPE. Written informed consent of the subject to participate. PatientS above 18 years of age will be included in the study.

Exclusion criteria

Exclusion criteria: Previous intolerance and/or adverse reactions to probiotics or the use of these products within the preceding 1 month. Pregnancy or lactation. Major systemic disease (e.g. heart failure, renal failure, malignant tumors, liver cirrhosis, etc.) Previous or current significant psychiatric co-morbidity Use of antibiotics in the preceding 1 month. Patient on any specific diet. Patient on any immunosuppressant drugs Patients who were unwilling to participate voluntarily in the study.

Design outcomes

Primary

MeasureTime frame
Eradication rates of H. pylori in both the groupsTimepoint: Eradication rates of H. pylori in both the groups

Secondary

MeasureTime frame
Overall adverse eventsTimepoint: 2 ,4 ,6 WEEKS;Compliance of therapyTimepoint: 2 AND 4 WEEKS;Changes in dyspeptic symptomsTimepoint: 2,4 AND 6 WEEKS;Quality of LifeTimepoint: 2,4 and 6 WEEKS

Countries

India

Contacts

Public ContactDr Vaneet Jearth

Postgraduate Institute of Medical Education and Research

vaneet.jearth@gmail.com08427550317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026