Gastrointestinal Disease, HELICOBACTER PYLORI INFECTIONS
Conditions
Keywords
IgY, Helicobacter pylori, clinical trial, Antibody, gastrointestinal disease
Brief summary
1. Investigating its effectiveness in removing bacteria in invivo conditions 2. Investigating the effectiveness in improving the clinical symptoms of patients
Interventions
BIOLOGICALHelicobacter pylori eradication therapy
12 grams of egg yolk powder containing about 2 grams of antibody twice a day for 2 weeks along with usual antibiotic treatment including OAC or omeprazole (40 mg/day), clarithromycin (1000 mg/day) and amoxicillin (2000 mg/day).
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Patients with gastritis or stomach ulcers whose Helicobacter infection has been confirmed by a doctor and age group 18 to 78 years, all genders, if accepted
Exclusion criteria
* Acute perforation of esophagus, stomach and duodenum Hyperlipidemic people Those who are allergic to egg proteins Patients with stomach cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory urea level (UBT) higher than cut off 50 | Determination of respiratory urea (UBT) at the beginning of the study and 8 weeks after the start of the intervention | This test is performed with the help of a diagnostic kit. After oral ingestion of a capsule containing labeled carbon and the patient's exhalation into the kit, the amount of urea breathed in is determined by the device. A UBT value greater than 50 means Helicobacter pylori infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examining the patient's clinical symptoms including: abdominal pain, nausea, vomiting and bloating. | During the treatment period for 4 weeks from the beginning of the intervention. | Based on the scoring of gastrointestinal symptoms (GSRS) in such a way that the score is calculated as follows: the number of participants with reduced abdominal pain: 0 (no symptoms), 1 (mild means the presence of tolerable symptoms), 2 (moderate means discomfort and interference) in normal activities), 3 (severe means inability to perform normal activities) -- the number of participants with reduced gastrointestinal symptoms: 0 (absence of nausea), 1 (temporary and short periods of nausea), 2 (frequent nausea) and long-term without vomiting), 3 (persistent nausea and frequent vomiting) -- the number of participants with reduced bloating: 0 (no bloating), 1 (short-term and temporary bloating), 2 (long-term but tolerable bloating), 3 (severe flatulence and interference in social functioning) |
Countries
Iran
Outcome results
None listed