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CompletedNCT06973889Hp IgYUpdated May 15, 2025

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

A Phase 2 interventional study of Helicobacter pylori eradication therapy in HELICOBACTER PYLORI INFECTIONS and Gastrointestinal Disease, sponsored by Mashhad University of Medical Sciences. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Mashhad University of Medical Sciences · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Dec 2023, registered May 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 78 Years
Sex
All
01

Study summary

  1. Investigating its effectiveness in removing bacteria in invivo conditions
  2. Investigating the effectiveness in improving the clinical symptoms of patients
02

Conditions studied

  • HELICOBACTER PYLORI INFECTIONS
  • Gastrointestinal Disease

Keywords

  • IgY
  • Helicobacter pylori
  • clinical trial
  • Antibody
  • gastrointestinal disease
03

In context

Gastrointestinal Diseases

548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 92 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Acute perforation of esophagus, stomach and duodenum Hyperlipidemic people Those who are allergic to egg proteins Patients with stomach cancer
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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).

    Biological: Helicobacter pylori eradication therapy

  • No intervention
    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)

Interventions

  • BiologicalHelicobacter 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).

06

What researchers measure

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.

    Time frame: 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.

    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.

07

Study locations

2 sites
  • Mashhad University of Medical Sciences
    Mashhad, Khorasan 9177945418, Iran, Islamic Republic of
  • Mashhad university of medical sciences
    Mashhad, Khorasan 9177948564, Iran, Islamic Republic of
08

References and documents

Publications

  • 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. PubMed 15298626 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2023 to primary completion in Dec 2024, 12 months.

Of 23 phase 2 interventional studies under Gastrointestinal Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 46. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2025
First posted
May 15, 2025
StartActual
Dec 4, 2023
Primary completionActual
Dec 30, 2024
CompletionActual
Jan 21, 2025
Last update
May 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06973889
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
zahra esmaeili (Student, Mashhad University of Medical Sciences) — Principal investigator
First posted
May 15, 2025
Start date
Dec 4, 2023
Primary completion
Dec 30, 2024
Completion
Jan 21, 2025
Last update
May 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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