Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis

NCT ID: NCT02721355

Last Updated: 2021-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

H. pylori positive patient volunteers that passed the selection criteria are recruited and divided into a test and a control group. Both groups are treated with a current treatment regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but only the test group received IgY-containing food supplement as an adjunctive measure for 15 days. The subjects are examined before and 4 weeks after the treatment initiation by Urea Breath Test (UBT) and gastro-endoscopy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Gastritis Caused by Helicobacter Pylori

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Food supplement GastimunHP

The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime

Group Type EXPERIMENTAL

GastimunHP

Intervention Type DIETARY_SUPPLEMENT

Health food supplement containing specific IgY against urease of H. pylori

Control

The subjects undergo the routine treatment regime without taking food supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GastimunHP

Health food supplement containing specific IgY against urease of H. pylori

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with gastritis or gastric ulcer who are positive to H. pylori

Exclusion Criteria

* People allergic to egg proteins
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dong Do Pharmaceutical Co.

INDUSTRY

Sponsor Role collaborator

Immunology Research Institute in Gifu

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Khien V Vu, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

108 Military Central Hospital

Hanoi, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BV108-15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.