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

Institute of Gastroenterology and Hepatology, Vietnam

Status: Terminated

Conditions: Peptic Ulcer; Helicobacter Pylori Infection

Treatments: Dietary Supplement: GastimunHp Plus; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04025983

TH1903

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

GastimunHp Plus

Experimental group

Description:

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

Treatment:

Dietary Supplement: GastimunHp Plus

Placebo

Placebo Comparator group

Description:

1 sachet of placebo twice daily during or after meals.

Treatment:

Other: Placebo