Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection

Conditions
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Helicobacter Pylori Infection, Peptic Ulcer

Intervention / Treatment
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* Dietary Supplement: GastimunHp Plus
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GastimunHp Plus<br>1 sachet of GastimunHp Plus twice daily during or after meals. | Dietary Supplement: GastimunHp Plus<br>* Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.<br>|
| Placebo Comparator: Placebo<br>1 sachet of placebo twice daily during or after meals. | Other: Placebo<br>* The placebo contains neither IgY nor L. johnsonii.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical improvement after 6-8 weeks | Symptom resolution evaluated clinically. | Six to eight weeks after recruitment | 
| Proportion of patients with adverse effects | Any adverse effects that are deemed related to the investigational product. | 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. | Six to eight weeks after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, peptic ulcer, Lactobacillus johnsonii, immunoglobin Y