Evaluation of IgY Antibody Efficacy in Egg Yolk Against Helicobacter Pylori in Bacterial Elimination and Clinical Symptoms Improvement of Gastrointestinal Patients

Mashhad University of Medical Sciences60 enrolled

Overview

1. Investigating its effectiveness in removing bacteria in invivo conditions 2. Investigating the effectiveness in improving the clinical symptoms of patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

HELICOBACTER PYLORI INFECTIONS Gastrointestinal Disease

Interventions

Helicobacter pylori eradication therapyBIOLOGICAL

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (2)

Mashhad University of Medical Sciences

Mashhad, Khorasan, Iran

Mashhad university of medical sciences

Mashhad, Khorasan, Iran

Outcomes

Primary Outcomes

Respiratory urea level (UBT) higher than cut off 50

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.

Time frame: Determination of respiratory urea (UBT) at the beginning of the study and 8 weeks after the start of the intervention

Secondary Outcomes

Examining the patient's clinical symptoms including: abdominal pain, nausea, vomiting and bloating.

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)

Time frame: During the treatment period for 4 weeks from the beginning of the intervention.

Data from ClinicalTrials.gov

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