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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
190
Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
The placebo contains neither IgY nor L. johnsonii.
Institute of Gastroenterology and Hepatology
Hanoi, Vietnam
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.
Time frame: Six to eight weeks after recruitment
Proportion of patients with clinical improvement after 6-8 weeks
Symptom resolution evaluated clinically.
Time frame: Six to eight weeks after recruitment
Proportion of patients with adverse effects
Any adverse effects that are deemed related to the investigational product.
Time frame: Six to eight weeks after recruitment
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.
Time frame: Six to eight weeks after recruitment
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