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| Name | Class |
|---|---|
| Dong Do Pharmaceutical Co. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food supplement GastimunHP | Experimental | The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime |
|
| Control | No Intervention | The subjects undergo the routine treatment regime without taking food supplement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GastimunHP | Dietary Supplement | Health food supplement containing specific IgY against urease of H. pylori |
|
| 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 |
| 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). |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khien V Vu, Ph. D | Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 108 Military Central Hospital | Hanoi | Vietnam |
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| ID | Title | Description |
|---|---|---|
| FG000 | Food Supplement GastimunHP | 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 |
| FG001 | Control | The subjects undergo the routine treatment regime without taking food supplement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Food Supplement GastimunHP | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | UBT value | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Food Supplement GastimunHP | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Van Sa Nguyen | Immunology Research Institute in Gifu | +819068053288 | nguyen@ew-nutrition.co.jp |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 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 |
The subjects undergo the routine treatment regime without taking food supplement |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | Control | The subjects undergo the routine treatment regime without taking food supplement | 0 | 41 | 0 | 41 |
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| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |