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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109381
Recruitment Status : Terminated (Poor efficacy (2 of 31 completing participants with H.pylori eradication))
First Posted : April 23, 2010
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Singapore General Hospital
Information provided by (Responsible Party):
Synergy Pharmaceuticals Pte. Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: GT08 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centre, Open-label, Non-controlled, Exploratory Safety and Efficacy Clinical Trial of GT08 in Volunteers and Patients Who Are Infected With Helicobacter Pylori
Study Start Date : May 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Arm Intervention/treatment
Experimental: Treatment with GT08
Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
Drug: GT08
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily

Primary Outcome Measures :
  1. Number of Participants With Eradication of H.Pylori Infection [ Time Frame: 4-6 weeks following treatment ]
    Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment

  2. Absence of Significant Gastric Abnormality Post-treatment (Initial Phase) [ Time Frame: up to 14 days of treatment ]
    Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).

Secondary Outcome Measures :
  1. Assessment of Adverse Events (AE) [ Time Frame: AE commencing within 30 days of initiation of treatment, followed until resolution ]
    Adverse event data will be collected in response to neutral questioning.

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Informed Consent prior to any study procedure
  • Age at least 21 years and up to 70 years
  • If female of childbearing potential who is sexually active, agrees to use acceptable methods of birth control throughout the study. Acceptable methods of birth control are: hormonal contraceptives (birth control pills), intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy.

Additional Inclusion Criteria for Initial Phase only

  • Healthy volunteers - can have gastrointestinal or other symptoms if these do not require medical treatment and are considered by the investigator to be clinically minor and irrelevant to the conduct of the study.
  • Positive laboratory serology for H.pylori
  • Positive Urea Breath Test for H.pylori
  • Willing to undergo two gastroscopy procedures

Additional Inclusion Criteria for Secondary Phase only

  • Either healthy volunteers or patients attending gastroenterology outpatient clinic - can have gastrointestinal or other symptoms if these are considered by the investigator to be clinically minor or irrelevant to the conduct of the study.
  • Positive diagnosis of current H.pylori infection, as diagnosed by positive Urea Breath Test and at least one of the following: 1) Positive laboratory serology for H.pylori, 2) known positive Campylobacter-like organism (CLO) test or H.pylori culture from a gastroscopy performed in the 1 year prior to Screening.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Clinically significant gastric disease, in the opinion of the investigator.
  • Significant disease or disorder on general medical examination, in the opinion of the investigator (general, respiratory, cardiovascular, renal, hepatic, neurological, bleeding tendency etc).
  • Regular or intermittent use of antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or antiplatelet medications is expected during the trial period.
  • Cessation of proton pump inhibitor or H2-blocker therapy for 2 weeks prior to Urea Breath Test is likely to not be in the best interests of the participant.
  • Laboratory values on blood testing that are outside of the laboratory normal range and considered clinically relevant by the investigator: the following will be screened Haemoglobin (Hb), bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, Alkaline Phosphatase, Urea, sodium (Na), potassium (K), creatinine (CRE).
  • Any contraindication to treatment with omeprazole, N-acetyl cysteine (NAC), or sodium bicarbonate.
  • Any evidence of organic or psychiatric disorders likely to result in poor compliance in the opinion of the investigator.
  • Previous participation in this trial at any time, or participation in any other clinical trial within the previous 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109381

Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Synergy Pharmaceuticals Pte. Ltd.
Singapore General Hospital
Principal Investigator: Ling Khoon Lin, MRCP, DPhil Singapore General Hospital

Responsible Party: Synergy Pharmaceuticals Pte. Ltd. Identifier: NCT01109381     History of Changes
Other Study ID Numbers: GT08-01
First Posted: April 23, 2010    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: March 2014

Keywords provided by Synergy Pharmaceuticals Pte. Ltd.:
bacterial infections
anti-infective agents
gastrointestinal agents
antibacterial agents
lauric acid
helicobacter infections
helicobacter pylori
non-antibiotic treatment

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action