NCT04025983

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

July 12, 2019

Last Update Submit

October 17, 2021

Conditions

Helicobacter Pylori InfectionPeptic Ulcer

Keywords

Helicobacter pyloripeptic ulcerLactobacillus johnsoniiimmunoglobin Y

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Proportion of patients with clinical improvement after 6-8 weeks

    Six to eight weeks after recruitment

  • Proportion of patients with adverse effects

    Six to eight weeks after recruitment

  • Proportion of patients with improvement of lesions on endoscopy

    Six to eight weeks after recruitment

Study Arms (2)

GastimunHp Plus

EXPERIMENTAL

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

Dietary Supplement: GastimunHp Plus

Placebo

PLACEBO COMPARATOR

1 sachet of placebo twice daily during or after meals.

Other: Placebo

Interventions

GastimunHp PlusDIETARY_SUPPLEMENT

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

GastimunHp Plus
PlaceboOTHER

The placebo contains neither IgY nor L. johnsonii.

Placebo

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Suspected malignant lesions.
  • Children under 10 years of age; pregnant or lactating women.
  • Allergic to chicken egg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Gastroenterology and Hepatology

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 19, 2019

Study Start

November 1, 2019

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

VN(1)