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

Synergy Pharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Helicobacter Pylori Infection

Treatments: Drug: GT08

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01109381

GT08-01

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Treatment with GT08

Experimental group

Description:

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

Treatment:

Drug: GT08