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

Phase 2

Completed

• Conditions: HELICOBACTER PYLORI INFECTIONS; Gastrointestinal Disease
• Interventions: Biological: Helicobacter pylori eradication therapy

• Registration Number: NCT06973889
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

1. Investigating its effectiveness in removing bacteria in invivo conditions

2. Investigating the effectiveness in improving the clinical symptoms of patients

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-21
• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Helicobacter 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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Mashhad University of Medical Sciences; 🇮🇷 Mashhad, Khorasan, Iran, Islamic Republic of

Mashhad university of medical sciences; 🇮🇷 Mashhad, Khorasan, Iran, Islamic Republic of