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

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth
IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth
Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline
IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth
Sponsored by
The Third Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Egg yolk antibody, Helicobacter pylori rescue therapy, Helicobacter pylori therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Third Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

study group

control group

the case group

the control group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Eradication rate of Helicobacter pylori
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 Outcome Measures

Relief of clinical symptoms (Symptom relief rate)
Assessment by questionnaire: Symptom relief rate = (number of people with relief of symptoms/total number of people) *100%
Adverse events
follow up to get the percentage of people with adverse reactions

Full Information

First Posted
June 4, 2022
Last Updated
December 6, 2022
Sponsor
The Third Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05410223
Brief Title
Efficacy and Safety Study of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection
Official Title
A Study on the Efficacy and Safety of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Egg yolk antibody, Helicobacter pylori rescue therapy, Helicobacter pylori therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
Arm Title
control group
Arm Type
Active Comparator
Arm Description
14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
Arm Title
the case group
Arm Type
Experimental
Arm Description
14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
Intervention Type
Drug
Intervention Name(s)
Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth
Intervention Description
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
Intervention Name(s)
IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth
Intervention Description
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
Intervention Name(s)
Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline
Intervention Description
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
Intervention Name(s)
IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth
Intervention Description
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
Primary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori
Description
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%
Time Frame
At four weeks after the completion of treatment (day 42±3)
Secondary Outcome Measure Information:
Title
Relief of clinical symptoms (Symptom relief rate)
Description
Assessment by questionnaire: Symptom relief rate = (number of people with relief of symptoms/total number of people) *100%
Time Frame
After drug treatment (day 14±3) and during follow-up (day 42±3)
Title
Adverse events
Description
follow up to get the percentage of people with adverse reactions
Time Frame
After drug treatment (day 14±3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 70 years old, male or female; Patients diagnosed with Hp infection; Failure of Hp eradication therapy; Although taking acid-suppressing drugs (PPI), the drug has been stopped for more than 2 weeks; Those who have not used antibiotics and (or) bismuth in the past 4 weeks; Understand and be willing to participate in this clinical trial and provide signed informed consent. Exclusion Criteria: Those with a history of allergy to drugs and egg yolk antibody products; Those with severe heart, liver, lung and kidney insufficiency; Those with a recent history of gastrointestinal bleeding, obstruction, perforation, tumor, and other serious organic diseases of the gastrointestinal tract; Those with mental illness or mental disorder that cannot be expressed normally; During the research period, those who are pregnant, breastfeeding, or have a childbearing plan recently; There are other persons who are not suitable for clinical trials of drugs No collaborators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CANXIA XU
Phone
+8613786176248
Email
xucanxia@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SHA CHENG
Organizational Affiliation
The Third Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CANXIA XU
Phone
+8613786176248
Email
xucanxia@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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