Skip to main content
OpenTrials
Completed

NCT Number: NCT06973889

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mashhad University of Medical Sciences, Mashhad, Khorasan, Iran

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helicobacter pylori eradication therapy

Biological

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 outcomes

  1. Respiratory urea level (UBT) higher than cut off 50

    Time frame: 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 outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

Evaluation of IgY Antibodies Effectiveness in Egg Yolk Against Helicobacter Pylori in Removing Bacteria and Improving Clinical Symptoms in the Patients

Acronym: Hp IgY

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.