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

Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam

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.

Study Overview

• Status: Completed
• Conditions: Chronic Gastritis Caused by Helicobacter Pylori
• Intervention / Treatment: Dietary supplement: GastimunHP

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • 108 Military Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• People allergic to egg proteins

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food supplement GastimunHP; The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime	Dietary supplement: GastimunHP; Health food supplement containing specific IgY against urease of H. pylori
No Intervention: Control; The subjects undergo the routine treatment regime without taking food supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UBT Values at Baseline and 8 Weeks	Urea Breath test (UBT) value was examined at baseline (0 week) and 8 weeks later. A commercial kit was used following the instructions from the manufacturer. A cut off value of 50 is considered to be positive. Higher UBT values indicate worse outcome.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks	Outcome measures are the Gastrointestinal Symptom Rating Scale (GSRS) scores using a four-point graded scale (0 = none: no symptoms; 1 = mild: awareness of sign or symptom, but easily tolerated; 2 = moderate: discomfort sufficient to cause interference with normal activities; 3 = severe: incapacitating with inability to perform normal activities).	4 weeks
Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks	Outcome measures are the Gastrointestinal Symptom Rating Scale (GSRS) scores using a four-point graded scale (0 = no nausea; 1 = occasional episodes of short duration; 2 = frequent and prolonged nausea, no vomiting; 3 = continuous nausea, frequent vomiting)	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reduced Bloating After 1 Week	Participants were asked to monitor stomach bloating after each meal daily during the first week of treatment. The participants that felt having less bloating were recorded to have reduced bloating.	1 week

Collaborators and Investigators

• Sponsor: Immunology Research Institute in Gifu
• Collaborators: Dong Do Pharmaceutical Co.
• Investigators: Principal Investigator: Khien V Vu, Ph. D, Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Gastric ulcer; Chronic gastritis; IgY
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Gastritis, Atrophic
• Other Study ID Numbers: BV108-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No