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

• Sponsor: Immunology Research Institute in Gifu (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02721355
• Collaborator: Dong Do Pharmaceutical Co. (Other)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Gastritis Caused by Helicobacter Pylori	Dietary Supplement: GastimunHP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. UBT Values at Baseline and 8 Weeks [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

1. Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks [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).

2. Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks [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)

Other Outcome Measures

1. Number of Participants With Reduced Bloating After 1 Week [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• People allergic to egg proteins

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	108 Military Central Hospital	Hanoi		Vietnam

Sponsors and Collaborators

• Immunology Research Institute in Gifu
• Dong Do Pharmaceutical Co.

Investigators

• Principal Investigator: Khien V Vu, Ph. D, Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Immunology Research Institute in Gifu
• ClinicalTrials.gov Identifier: NCT02721355
• Other Study ID Numbers: BV108-15
• First Posted: Mar 29, 2016
• Last Update Posted: Jan 28, 2021
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Immunology Research Institute in Gifu: Chronic gastritis; Gastric ulcer; Helicobacter pylori; IgY
• Additional relevant MeSH terms: Gastritis; Gastritis, Atrophic

Study Results

Participant Flow

Arm/Group Title	Food Supplement GastimunHP	Control
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	The subjects undergo the routine treatment regime without taking food supplement
Period Title: Overall Study
STARTED	42	42
COMPLETED	36	41
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	Food Supplement GastimunHP	Control	Total
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	The subjects undergo the routine treatment regime without taking food supplement	Total of all reporting groups
Overall Participants	36	41	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.1 (12.7)	44.2 (12.5)	46.05 (12.7)
Sex: Female, Male (Count of Participants)
Female	16 44.4%	22 53.7%	38 49.4%
Male	20 55.6%	19 46.3%	39 50.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Food Supplement GastimunHP	Control
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	The subjects undergo the routine treatment regime without taking food supplement
Measure Participants	36	41
Baseline	161.64 (83.53)	158.54 (43.73)
After 8 weeks	49.42 (44.21)	73.37 (30)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Food Supplement GastimunHP	Control
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	The subjects undergo the routine treatment regime without taking food supplement
Measure Participants	36	41
Reduced pain after 1 week	19 52.8%	16 39%
Reduced pain after 4 weeks	25 69.4%	25 61%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Food Supplement GastimunHP	Control
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	The subjects undergo the routine treatment regime without taking food supplement
Measure Participants	36	41
Number of participants with reduced GSRS scores after 1 week	18 50%	15 36.6%
Number of participants with reduced GSRS scores after 4 weeks	25 69.4%	25 61%

4. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Food Supplement GastimunHP	Control
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	The subjects undergo the routine treatment regime without taking food supplement
Measure Participants	36	41
Count of Participants [Participants]	18 50%	15 36.6%

Adverse Events

Arm/Group Title	Food Supplement GastimunHP		Control
Arm/Group Description	The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori		The subjects undergo the routine treatment regime without taking food supplement
All Cause Mortality
	Food Supplement GastimunHP		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Food Supplement GastimunHP		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Food Supplement GastimunHP		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)		0/41 (0%)
Gastrointestinal disorders
diarrhea	1/36 (2.8%)	1	0/41 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.