An interventional study of GastimunHp Plus and Placebo in Helicobacter Pylori Infection and Peptic Ulcer, sponsored by Institute of Gastroenterology and Hepatology, Vietnam. Terminated at 1 site in Vietnam. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Institute of Gastroenterology and Hepatology, Vietnam · Not applicable, Interventional, and Supportive care
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 190 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Institute of Gastroenterology and Hepatology, Vietnam is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 sachet of GastimunHp Plus twice daily during or after meals.
Dietary Supplement: GastimunHp Plus
1 sachet of placebo twice daily during or after meals.
Other: Placebo
Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
The placebo contains neither IgY nor L. johnsonii.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Institute of Gastroenterology and Hepatology, Vietnam