Helicobacter Pylori Infection Clinical Trial
— GasHpOfficial title:
Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
Verified date | October 2021 |
Source | Institute of Gastroenterology and Hepatology, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Challenges in the treatment of Helicobacter pylori (H. pylori) include increasing antimicrobial resistance and patient's low tolerance to some regimens. Lactobacillus johnsonii (L. johnsonii) and Immunoglobulin Y (IgY) have been shown to decrease the amount and activity of H. pylori in human stomach and can increase patient's tolerance. We conduct a single-center double-masked randomized controlled trial to evaluate the effectiveness of GastimunHp Plus (a product combining L. johnsonii and IgY) in improving the clearance of H. pylori after six to eight weeks of treatment and side effects of H. pylori treatment. H. pylori is tested by C13- or C14-urea breath test.
Status | Terminated |
Enrollment | 190 |
Est. completion date | October 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with gastritis, duodenitis, or peptic ulcer. - Tested positive with Helicobacter pylori using C13- or C14-urea breath test or urease test. - Indicated for Helicobacter pylori eradication. Exclusion Criteria: - Suspected malignant lesions. - Children under 10 years of age; pregnant or lactating women. - Allergic to chicken egg. |
Country | Name | City | State |
---|---|---|---|
Vietnam | Institute of Gastroenterology and Hepatology | Hanoi |
Lead Sponsor | Collaborator |
---|---|
Institute of Gastroenterology and Hepatology, Vietnam |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with negative urea breath test after 6-8 weeks | Patients tested negative with Helicobacter pylori using C13- or C14-urea breath test. | Six to eight weeks after recruitment | |
Secondary | Proportion of patients with clinical improvement after 6-8 weeks | Symptom resolution evaluated clinically. | Six to eight weeks after recruitment | |
Secondary | Proportion of patients with adverse effects | Any adverse effects that are deemed related to the investigational product. | Six to eight weeks after recruitment | |
Secondary | Proportion of patients with improvement of lesions on endoscopy | Improvement of lesions detected on baseline on upper gastrointestinal endoscopy. Improvement was determined by expert's opinion. | Six to eight weeks after recruitment |
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