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

NCT ID: NCT06973889

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2025-01-21

Brief Summary

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

Detailed Description

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Conditions

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HELICOBACTER PYLORI INFECTIONS Gastrointestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

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).

Group Type EXPERIMENTAL

Helicobacter pylori eradication therapy

Intervention Type 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).

Control

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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zahra esmaeili

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mashhad University of Medical Sciences

Mashhad, Khorasan, Iran

Site Status

Mashhad university of medical sciences

Mashhad, Khorasan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 15298626 (View on PubMed)

Other Identifiers

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IR.MUMS.REC.1401.381

Identifier Type: -

Identifier Source: org_study_id

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