Chronic Gastritis Caused by Helicobacter Pylori
Conditions
Keywords
Chronic gastritis, Gastric ulcer, Helicobacter pylori, IgY
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.
Interventions
DIETARY_SUPPLEMENTGastimunHP
Health food supplement containing specific IgY against urease of H. pylori
Sponsors
Dong Do Pharmaceutical Co.
Immunology Research Institute in Gifu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with gastritis or gastric ulcer who are positive to H. pylori
Exclusion criteria
* People allergic to egg proteins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| Control The subjects undergo the routine treatment regime without taking food supplement | 41 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 1 |
Baseline characteristics
| Characteristic | Food Supplement GastimunHP | Control | Total |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 12.7 | 44.2 years STANDARD_DEVIATION 12.5 | 46.05 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 16 Participants | 22 Participants | 38 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 36 | 0 / 41 |
| serious Total, serious adverse events | 0 / 36 | 0 / 41 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Food Supplement GastimunHP | UBT Values at Baseline and 8 Weeks | Baseline | 161.64 UBT value | Standard Deviation 83.53 |
| Food Supplement GastimunHP | UBT Values at Baseline and 8 Weeks | After 8 weeks | 49.42 UBT value | Standard Deviation 44.21 |
| Control | UBT Values at Baseline and 8 Weeks | Baseline | 158.54 UBT value | Standard Deviation 43.73 |
| Control | UBT Values at Baseline and 8 Weeks | After 8 weeks | 73.37 UBT value | Standard Deviation 30 |
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)
Time frame: 4 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Food Supplement GastimunHP | Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks | Number of participants with reduced GSRS scores after 1 week | 18 Participants |
| Food Supplement GastimunHP | Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks | Number of participants with reduced GSRS scores after 4 weeks | 25 Participants |
| Control | Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks | Number of participants with reduced GSRS scores after 1 week | 15 Participants |
| Control | Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks | Number of participants with reduced GSRS scores after 4 weeks | 25 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).
Time frame: 4 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Food Supplement GastimunHP | Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks | Reduced pain after 1 week | 19 Participants |
| Food Supplement GastimunHP | Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks | Reduced pain after 4 weeks | 25 Participants |
| Control | Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks | Reduced pain after 1 week | 16 Participants |
| Control | Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks | Reduced pain after 4 weeks | 25 Participants |
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.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Food Supplement GastimunHP | Number of Participants With Reduced Bloating After 1 Week | 18 Participants |
| Control | Number of Participants With Reduced Bloating After 1 Week | 15 Participants |