Chronic Gastritis Caused by Helicobacter Pylori Clinical Trial
Official title:
Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam
| NCT number | NCT02721355 |
| Other study ID # | BV108-15 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2013 |
| Est. completion date | June 2016 |
| Verified date | August 2016 |
| Source | Immunology Research Institute in Gifu |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 84 |
| Est. completion date | June 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility | Inclusion Criteria: - Patients with gastritis or gastric ulcer who are positive to H. pylori Exclusion Criteria: - People allergic to egg proteins |
| Country | Name | City | State |
|---|---|---|---|
| Vietnam | 108 Military Central Hospital | Hanoi |
| Lead Sponsor | Collaborator |
|---|---|
| Immunology Research Institute in Gifu | Dong Do Pharmaceutical Co. |
Vietnam,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| 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. | 8 weeks | |
| 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). | 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) | 4 weeks |