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

NCT ID: NCT04025983

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The investigational product (IP) is compared with a placebo. The IP and placebo are manufactured by the sponsor and then sent to the trial pharmacist. They are only different in a number in the package label, and only the sponsor knows which number is the IP and will call them "product I" and "product II". This labelling is not revealed to the study team, the trial pharmacist, and the biostatistician.

In the random number sequences generated by the biostatistician, the study numbers will be allocated to either "product I" or "product II". The trial pharmacist is responsible for making product bags using study numbers and allocation given by the biostatistician. The product bags are transferred to the study team. In this way, the study team and patients are completely masked to the allocation.

Study Groups

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GastimunHp Plus

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

Group Type EXPERIMENTAL

GastimunHp Plus

Intervention Type DIETARY_SUPPLEMENT

Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.

Placebo

1 sachet of placebo twice daily during or after meals.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The placebo contains neither IgY nor L. johnsonii.

Interventions

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GastimunHp Plus

Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo contains neither IgY nor L. johnsonii.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Gastroenterology and Hepatology, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Gastroenterology and Hepatology

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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TH1903

Identifier Type: -

Identifier Source: org_study_id