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

NCT ID: NCT05410223

Last Updated: 2022-12-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Helicobacter Pylori Infection

Keywords

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Egg yolk antibody Helicobacter pylori rescue therapy Helicobacter pylori therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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study group

14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

control group

14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Group Type ACTIVE_COMPARATOR

IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth

Intervention Type DRUG

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

the case group

14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

the control group

14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Group Type ACTIVE_COMPARATOR

IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth

Intervention Type DRUG

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

Interventions

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Yolk 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

Intervention Type DRUG

IIaprazole, 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

Intervention Type DRUG

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

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.

Intervention Type DRUG

IIaprazole, 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SHA CHENG

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Locations

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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CANXIA XU

Role: CONTACT

Phone: +8613786176248

Email: [email protected]

Facility Contacts

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CANXIA XU

Role: primary

Other Identifiers

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xucanxia2020

Identifier Type: -

Identifier Source: org_study_id