Trial | NCT04025983  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    190
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 Started
Nov 01
2019
Primary Completion
Apr 01
2021
Study Completion
Oct 01
2021
Last Update
Oct 19
2021

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.

GastimunHp Plus Experimental

1 sachet of GastimunHp Plus twice daily during or after meals.

Placebo Placebo Comparator

1 sachet of placebo twice daily during or after meals.

Criteria 

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.
No Results Posted