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

NCT06973889 | Completed Phase 2

• 1 other identifier: IR.MUMS.REC.1401.381
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HELICOBACTER PYLORI INFECTIONS; Gastrointestinal Disease

Keywords

IgY; Helicobacter pylori; clinical trial; Antibody; gastrointestinal disease

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Biological: Helicobacter pylori eradication therapy

Control

NO INTERVENTION

normal egg yolk powder without IgY in the amount of 12 grams 2 times a day for 2 weeks along with usual antibiotic treatment OAC or omeprazole (40 mg/day), clarithromycin (1000 mg/day) and amoxicillin (2000 mg/day)

Interventions

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).

Intervention

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute perforation of esophagus, stomach and duodenum Hyperlipidemic people Those who are allergic to egg proteins Patients with stomach cancer

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (2)

Mashhad University of Medical Sciences

Mashhad, Khorasan, 9177945418, Iran

Location

Mashhad university of medical sciences

Mashhad, Khorasan, 9177948564, Iran

Location

Related Publications (1)

• Suzuki H, Nomura S, Masaoka T, Goshima H, Kamata N, Kodama Y, Ishii H, Kitajima M, Nomoto K, Hibi T. Effect of dietary anti-Helicobacter pylori-urease immunoglobulin Y on Helicobacter pylori infection. Aliment Pharmacol Ther. 2004 Jul;20 Suppl 1:185-92. doi: 10.1111/j.1365-2036.2004.02027.x.

  PMID: 15298626 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: December 4, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 21, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

IR (2)