NCT04025983

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Institute of Gastroenterology and Hepatology, Vietnam · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Helicobacter Pylori Infection
• Peptic Ulcer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GastimunHp Plus	Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
OTHER	Placebo	The placebo contains neither IgY nor L. johnsonii.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-04-01
• Completion: 2021-10-01
• First posted: 2019-07-19
• Last updated: 2021-10-19

Locations

1 site across 1 country: Vietnam