Investigating the effect of Y antibody in the treatment of Helicobacter infection

Investigating the effectiveness of IgY antibody in egg yolk against Helicobacter pylori in removing the bacterium and improving the clinical symptoms of patients with gastrointestinal infections.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190924044863N2

Enrollment

Registered

2023-03-18

Start date

2023-04-04

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection. Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Interventions

Intervention 1: Intervention group: The first intervention group: during the treatment, in addition to the usual antibiotics, including OAC or omeprazole (40 mg per day), amoxicillin (2000 mg per day)

Eligibility

Sex/Gender

All

Age

10 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with gastritis or peptic ulcer whose Helicobacter pylori test (UBT) is positive Age group 10 to 75 years All genders if consent is 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

Design outcomes

Primary

Measure	Time frame
Respiratory urea level (UBT) higher than cut off 4. Timepoint: Determination of respiratory urea (UBT) at the beginning of the study and 8 weeks after the start of the intervention. Method of measurement: 50 mg of labelled carbon-13 is dissolved in urea with 100 ml of water, and after its oral consumption, the amount of labelled carbon is determined by the device following the patient's exhalation. A UBT value greater than 4% means Helicobacter pylori infection.;Examining the patient's clinical symptoms including: abdominal pain, nausea, vomiting and bloating. Timepoint: During the treatment period for 4 weeks from the beginning of the intervention. Method of measurement: 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).	—

Measure

Time frame

Respiratory urea level (UBT) higher than cut off 4. Timepoint: Determination of respiratory urea (UBT) at the beginning of the study and 8 weeks after the start of the intervention. Method of measurement: 50 mg of labelled carbon-13 is dissolved in urea with 100 ml of water, and after its oral consumption, the amount of labelled carbon is determined by the device following the patient's exhalation. A UBT value greater than 4% means Helicobacter pylori infection.;Examining the patient's clinical symptoms including: abdominal pain, nausea, vomiting and bloating. Timepoint: During the treatment period for 4 weeks from the beginning of the intervention. Method of measurement: 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).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Esmaeili

Mashhad University of Medical Sciences

Esmaeiliz982@mums.ac.ir+98 51 3845 3239

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026