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

Helicobacter Pylori Infection Clinical Trial

— GasHp  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04025983
• Other study ID #: TH1903
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Institute of Gastroenterology and Hepatology, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: October 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections
• Peptic Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Vietnam	Institute of Gastroenterology and Hepatology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Gastroenterology and Hepatology, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients with clinical improvement after 6-8 weeks	Symptom resolution evaluated clinically.	Six to eight weeks after recruitment
Secondary	Proportion of patients with adverse effects	Any adverse effects that are deemed related to the investigational product.	Six to eight weeks after recruitment
Secondary	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