Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori

NCT01109381 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-04-02

Study results available
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Summary

At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in triple therapy. This study explores a non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with omeprazole following administration of a mucolytic agent to kill H.pylori topically in the stomach.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

GT08

GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER
  • Synergy Pharmaceuticals Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Ling Khoon Lin, MRCP, DPhil · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01109381 on ClinicalTrials.gov