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

October 17, 2021 updated by: Institute of Gastroenterology and Hepatology, Vietnam
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Institute of Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GastimunHp Plus
1 sachet of GastimunHp Plus twice daily during or after meals.
Dietary supplement: GastimunHp Plus
Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
Placebo Comparator: Placebo
1 sachet of placebo twice daily during or after meals.
Other: Placebo
The placebo contains neither IgY nor L. johnsonii.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with negative urea breath test after 6-8 weeks
Time Frame: Six to eight weeks after recruitment
Patients tested negative with Helicobacter pylori using C13- or C14-urea breath test.
Six to eight weeks after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with clinical improvement after 6-8 weeks
Time Frame: Six to eight weeks after recruitment
Symptom resolution evaluated clinically.
Six to eight weeks after recruitment
Proportion of patients with adverse effects
Time Frame: Six to eight weeks after recruitment
Any adverse effects that are deemed related to the investigational product.
Six to eight weeks after recruitment
Proportion of patients with improvement of lesions on endoscopy
Time Frame: Six to eight weeks after recruitment
Improvement of lesions detected on baseline on upper gastrointestinal endoscopy. Improvement was determined by expert's opinion.
Six to eight weeks after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Gastroenterology and Hepatology, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

July 12, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 17, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH1903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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