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

Primary Purpose

Helicobacter Pylori Infection, Peptic Ulcer

Status
Terminated
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
GastimunHp Plus
Placebo
Sponsored by
Institute of Gastroenterology and Hepatology, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, peptic ulcer, Lactobacillus johnsonii, immunoglobin Y

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Gastroenterology and Hepatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GastimunHp Plus

Placebo

Arm Description

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

1 sachet of placebo twice daily during or after meals.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients with clinical improvement after 6-8 weeks
Symptom resolution evaluated clinically.
Proportion of patients with adverse effects
Any adverse effects that are deemed related to the investigational product.
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.

Full Information

First Posted
July 12, 2019
Last Updated
October 17, 2021
Sponsor
Institute of Gastroenterology and Hepatology, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT04025983
Brief Title
Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
Acronym
GasHp
Official Title
Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was slow and disrupted by COVID-19.
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Gastroenterology and Hepatology, Vietnam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Peptic Ulcer
Keywords
Helicobacter pylori, peptic ulcer, Lactobacillus johnsonii, immunoglobin Y

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GastimunHp Plus
Arm Type
Experimental
Arm Description
1 sachet of GastimunHp Plus twice daily during or after meals.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 sachet of placebo twice daily during or after meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
GastimunHp Plus
Intervention Description
Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo contains neither IgY nor L. johnsonii.
Primary Outcome Measure Information:
Title
Proportion of patients with negative urea breath test after 6-8 weeks
Description
Patients tested negative with Helicobacter pylori using C13- or C14-urea breath test.
Time Frame
Six to eight weeks after recruitment
Secondary Outcome Measure Information:
Title
Proportion of patients with clinical improvement after 6-8 weeks
Description
Symptom resolution evaluated clinically.
Time Frame
Six to eight weeks after recruitment
Title
Proportion of patients with adverse effects
Description
Any adverse effects that are deemed related to the investigational product.
Time Frame
Six to eight weeks after recruitment
Title
Proportion of patients with improvement of lesions on endoscopy
Description
Improvement of lesions detected on baseline on upper gastrointestinal endoscopy. Improvement was determined by expert's opinion.
Time Frame
Six to eight weeks after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institute of Gastroenterology and Hepatology
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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