Helicobacter Pylori Infection
Conditions
Keywords
bacterial infections, anti-infective agents, gastrointestinal agents, antibacterial agents, omeprazole, lauric acid, n-acetylcysteine, helicobacter infections, helicobacter pylori, non-antibiotic 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.
Interventions
DRUGGT08
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily
Sponsors
Singapore General Hospital
Synergy Pharmaceuticals Pte. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Eradication of H.Pylori Infection | 4-6 weeks following treatment | Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment |
| Absence of Significant Gastric Abnormality Post-treatment (Initial Phase) | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Adverse Events (AE) | AE commencing within 30 days of initiation of treatment, followed until resolution | Adverse event data will be collected in response to neutral questioning. |
Countries
Singapore
Participant flow
Recruitment details
Healthy volunteers were recruited, with the first volunteer consenting for screening on 13 May 2010. A total of 205 healthy volunteers were screened for the study, with 164 not being infected with H.pylori and 8 not entering the trial for other inclusion/exclusion reasons.
Pre-assignment details
No group assignment - all participants included were to receive trial treatment. Following consent to take part in the study, participants had a pre-treatment gastroscopy to exclude significant existing upper GI disease. Then all received omeprazole 40mg daily for 1 week prior to receiving the investigational GT08 treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Initial phase - omeprazole, 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
GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Region of Enrollment Singapore | 33 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)
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).
Time frame: up to 14 days of treatment
Population: All 21 Initial Phase participants had a pretreatment gastroscopy, and 20 had post-treatment gastroscopy (one participant prematurely discontinued the study prior to receiving GT08, and the participant later lost to follow up had a post-treatment gastroscopy before being lost to follow up)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With GT08 | Absence of Significant Gastric Abnormality Post-treatment (Initial Phase) | 20 participants |
Primary
Number of Participants With Eradication of H.Pylori Infection
Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment
Time frame: 4-6 weeks following treatment
Population: Two participants did not complete the study, one discontinuing after experiencing adverse events while receiving only the initial study omeprazole, and the other participant left Singapore before they had their final urea breath test. All other study participants were analysed for efficacy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With GT08 | Number of Participants With Eradication of H.Pylori Infection | 2 participants |
Secondary
Assessment of Adverse Events (AE)
Adverse event data will be collected in response to neutral questioning.
Time frame: AE commencing within 30 days of initiation of treatment, followed until resolution
Population: All participants entering the study are included in the safety analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With GT08 | Assessment of Adverse Events (AE) | 12 participants |