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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 September 2016
Main ID:  NCT02721355
Date of registration: 03/03/2016
Prospective Registration: No
Primary sponsor: Immunology Research Institute in Gifu
Public title: Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis
Scientific title: Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam
Date of first enrolment: June 2013
Target sample size: 77
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02721355
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Vietnam
Contacts
Name:     Khien V Vu, Ph. D
Address: 
Telephone:
Email:
Affiliation:  Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam
Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- People allergic to egg proteins



Age minimum: 2 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Gastritis Caused by Helicobacter Pylori
Intervention(s)
Dietary Supplement: GastimunHP
Primary Outcome(s)
Effect of IgY in combination with EAC on Helicobacter pylori eradication in patients with chronic gastritis [Time Frame: 4 weeks]
Secondary Outcome(s)
Effect of IgY in combination with EAC on bloating [Time Frame: 4 weeks]
Effect of IgY in combination with EAC on severity of abdominal pain. [Time Frame: 4 weeks]
Effect of IgY in combination with EAC on nausea and vomiting [Time Frame: 4 weeks]
Secondary ID(s)
BV108-15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Dong Do Pharmaceutical Co.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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