Efficacy and Safety Study of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection

A Study on the Efficacy and Safety of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05410223

Enrollment

100

Registered

2022-06-08

Start date

2021-04-06

Completion date

2022-12-01

Last updated

2022-12-09

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

Conditions

Helicobacter Pylori Infection

Keywords

Egg yolk antibody, Helicobacter pylori rescue therapy, Helicobacter pylori therapy

Brief summary

Helicobacter pylori is an important pathogenic factor for gastrointestinal diseases such as gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer.However, with the increasing use of antibiotics, antibiotic resistance of Helicobacter pylori continues to rise. In this study, we used egg yolk antibody combined with bismuth quadruple therapy to treat patients with Helicobacter pylori infection, and observed the eradication rate of Helicobacter pylori, the relief of clinical symptoms and the incidence of adverse reactions.

Detailed description

Background: Helicobacter pylori is an important pathogenic factor for gastrointestinal diseases such as gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer.However, with the increasing use of antibiotics, antibiotic resistance of Helicobacter pylori continues to rise. Therefore, it is of great significance to explore new methodsfor the treatment of Helicobacter pylori. Methods: A total of 200 patients who failed to eradicate Helicobacter pylori were included and randomly divided into control group and study group. The research group was treated with egg yolk antibody combined with bismuth quadruple therapy, and the research group was treated with bismuth quadruple therapy for a total of 14 days. The eradication rate of Helicobacter pylori was calculated according to intention-to-treat and by-protocol analysis, and the symptom remission rate and adverse reactions were recorded during the treatment period.

Interventions

DRUGYolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth

Yolk antibody: 7g\*10 board/box, produced by Beijing Yucheng Health Technology Co., Ltd. Ilaprazole: 5mg\*6 capsules/box, produced by Livzon Pharmaceutical Group Inc. Amoxicillin: 250mg\*50 capsules/box, produced by Hainan General Sanyo Pharmaceutical Co., Ltd. Clarithromycin: 500mg\*6 capsules/box, produced by Henan Fusen Pharmaceutical Co., Ltd. Furazolidone: 0.1g\*28 pieces/bag, produced by Tianjin Lisheng Pharmaceutical Co., Ltd. Doxycycline: 0.1g\*10 capsules/box, produced by Jiangsu Yongxin Pharmaceutical Co., Ltd. bismuth :55mg\*36 capsules/box, produced by Shanxi Xinbaoyuan Pharmaceutical Co.,Ltd

DRUGIIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth

Ilaprazole: 5mg\*6 capsules/box, produced by Livzon Pharmaceutical Group Inc. Amoxicillin: 250mg\*50 capsules/box, produced by Hainan General Sanyo Pharmaceutical Co., Ltd. Clarithromycin: 500mg\*6 capsules/box, produced by Henan Fusen Pharmaceutical Co., Ltd. Furazolidone: 0.1g\*28 pieces/bag, produced by Tianjin Lisheng Pharmaceutical Co., Ltd. Doxycycline: 0.1g\*10 capsules/box, produced by Jiangsu Yongxin Pharmaceutical Co., Ltd. bismuth :55mg\*36 capsules/box, produced by Shanxi Xinbaoyuan Pharmaceutical Co.,Ltd

DRUGYolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline

DRUGIIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age 18 to 70 years old, male or female; 2. Patients diagnosed with Hp infection; 3. Failure of Hp eradication therapy; 4. Although taking acid-suppressing drugs (PPI), the drug has been stopped for more than 2 weeks; 5. Those who have not used antibiotics and (or) bismuth in the past 4 weeks; 6. Understand and be willing to participate in this clinical trial and provide signed informed consent.

Exclusion criteria

1. Those with a history of allergy to drugs and egg yolk antibody products; 2. Those with severe heart, liver, lung and kidney insufficiency; 3. Those with a recent history of gastrointestinal bleeding, obstruction, perforation, tumor, and other serious organic diseases of the gastrointestinal tract; 4. Those with mental illness or mental disorder that cannot be expressed normally; 5. During the research period, those who are pregnant, breastfeeding, or have a childbearing plan recently; 6. There are other persons who are not suitable for clinical trials of drugs 7. No collaborators.

Design outcomes

Primary

Measure	Time frame	Description
Eradication rate of Helicobacter pylori	At four weeks after the completion of treatment (day 42±3)	Detected by 13C-urea breath test (13C-UBT) or 14C-urea breath test (14-UBT), Eradication rate=(Number of successful eradication / total number of eradication)\*100%

Secondary

Measure	Time frame	Description
Relief of clinical symptoms (Symptom relief rate)	After drug treatment (day 14±3) and during follow-up (day 42±3)	Assessment by questionnaire: Symptom relief rate = (number of people with relief of symptoms/total number of people) \*100%
Adverse events	After drug treatment (day 14±3)	follow up to get the percentage of people with adverse reactions

Countries

China

Contacts

Primary ContactCANXIA XU

xucanxia@163.com+8613786176248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026