Helicobacter Pylori InfectionGasHpNCT04025983
Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
A study testing GastimunHp Plus in people with Helicobacter Pylori Infection and Peptic Ulcer, run by Institute of Gastroenterology and Hepatology, Vietnam at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Helicobacter Pylori Infection, Peptic Ulcer
- What is being tested?
- GastimunHp Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Suspected malignant lesions.
- Children under 10 years of age; pregnant or lactating women.
- Allergic to chicken egg.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer
- Being tested
- GastimunHp Plus, Placebo
- Keywords
- Helicobacter pylori, peptic ulcer, Lactobacillus johnsonii, immunoglobin Y
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastimunHp PlusDietary supplement
Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
PlaceboOther
The placebo contains neither IgY nor L. johnsonii.
| Study group | Role | What they receive |
|---|---|---|
| GastimunHp Plus | Experimental | 1 sachet of GastimunHp Plus twice daily during or after meals. Receives: Dietary Supplement: GastimunHp Plus |
| Placebo | Placebo comparator | 1 sachet of placebo twice daily during or after meals. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six to eight weeks after recruitment
Secondary outcomes (3)
Proportion of patients with clinical improvement after 6-8 weeks
Symptom resolution evaluated clinically.
Measured: Six to eight weeks after recruitment
Proportion of patients with adverse effects
Any adverse effects that are deemed related to the investigational product.
Measured: Six to eight weeks after recruitment
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.
Measured: Six to eight weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Nov 2019
- Primary completion1 Apr 2021
- Study completion1 Oct 2021
Why it stopped: Recruitment was slow and disrupted by COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Gastroenterology and Hepatology, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025983
- Sponsor's protocol ID
- TH1903
- Acronym
- GasHp
- Status last verified
- Oct 2021
- First submitted
- 12 Jul 2019
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT04025983
- Acronym / sponsor ID
- GasHp / TH1903
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer
- Keywords
- Helicobacter pylori, peptic ulcer, Lactobacillus johnsonii, immunoglobin Y
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was slow and disrupted by COVID-19.
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Institute of Gastroenterology and Hepatology, VietnamUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GastimunHp Plus | Experimental | Dietary Supplement: GastimunHp Plus1 sachet of GastimunHp Plus twice daily during or after meals. |
| Placebo | Placebo comparator | Other: Placebo1 sachet of placebo twice daily during or after meals. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Suspected malignant lesions.
- Children under 10 years of age; pregnant or lactating women.
- Allergic to chicken egg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastimunHp PlusEach sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088. | Dietary supplement | GastimunHp Plus |
| PlaceboThe placebo contains neither IgY nor L. johnsonii. | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
Proportion of patients with clinical improvement after 6-8 weeks
Time frame: Six to eight weeks after recruitment
Proportion of patients with adverse effects
Time frame: Six to eight weeks after recruitment
Proportion of patients with improvement of lesions on endoscopy
Time frame: Six to eight weeks after recruitment
Results and safety
The study was stopped early (reason given: Recruitment was slow and disrupted by COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GastimunHp Plus in people with Helicobacter Pylori Infection and Peptic Ulcer, run by Institute of Gastroenterology and Hepatology, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was slow and disrupted by COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with negative urea breath test after 6-8 weeks (time frame: Six to eight weeks after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.