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

Primary Purpose

Chronic Gastritis Caused by Helicobacter Pylori

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
GastimunHP
Sponsored by
Immunology Research Institute in Gifu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Gastritis Caused by Helicobacter Pylori focused on measuring Chronic gastritis, Gastric ulcer, Helicobacter pylori, IgY

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • People allergic to egg proteins

Sites / Locations

  • 108 Military Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Food supplement GastimunHP

Control

Arm Description

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

The subjects undergo the routine treatment regime without taking food supplement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)

Full Information

First Posted
March 3, 2016
Last Updated
January 7, 2021
Sponsor
Immunology Research Institute in Gifu
Collaborators
Dong Do Pharmaceutical Co.
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1. Study Identification

Unique Protocol Identification Number
NCT02721355
Brief Title
Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis
Official Title
Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunology Research Institute in Gifu
Collaborators
Dong Do Pharmaceutical Co.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gastritis Caused by Helicobacter Pylori
Keywords
Chronic gastritis, Gastric ulcer, Helicobacter pylori, IgY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food supplement GastimunHP
Arm Type
Experimental
Arm Description
The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime
Arm Title
Control
Arm Type
No Intervention
Arm Description
The subjects undergo the routine treatment regime without taking food supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
GastimunHP
Intervention Description
Health food supplement containing specific IgY against urease of H. pylori
Primary Outcome Measure Information:
Title
UBT Values at Baseline and 8 Weeks
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks
Description
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).
Time Frame
4 weeks
Title
Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks
Description
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)
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Reduced Bloating After 1 Week
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with gastritis or gastric ulcer who are positive to H. pylori Exclusion Criteria: People allergic to egg proteins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khien V Vu, Ph. D
Organizational Affiliation
Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam
Official's Role
Principal Investigator
Facility Information:
Facility Name
108 Military Central Hospital
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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