Clinical trial NCT01109381: Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Helicobacter Pylori Infection
Keywords: bacterial infections
anti-infective agents
gastrointestinal agents
antibacterial agents
omeprazole
lauric acid
n-acetylcysteine
helicobacter infections
helicobacter pylori
non-antibiotic treatment
Lead sponsor: Synergy Pharmaceuticals Pte. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Singapore General Hospital
First posted: 2010-04-23
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Eradication of H.Pylori Infection
timeFrame: 4-6 weeks following treatment
measure: Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)
timeFrame: up to 14 days of treatment
Secondary outcomes:
measure: Assessment of Adverse Events (AE)
timeFrame: AE commencing within 30 days of initiation of treatment, followed until resolution
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Ling Khoon Lin, MRCP, DPhil
role: PRINCIPAL_INVESTIGATOR
References: