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

Study Overview
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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.

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth
* Drug: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth
* Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline
* Drug: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth | Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth<br>* 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<br>|
| Active Comparator: control group<br>14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth | Drug: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth<br>* 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<br>|
| Experimental: the case group<br>14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline | Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline<br>* 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.<br>|
| Active Comparator: the control group<br>14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth | Drug: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | At four weeks after the completion of treatment (day 42±3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | After drug treatment (day 14±3) and during follow-up (day 42±3) | 
| Adverse events | follow up to get the percentage of people with adverse reactions | After drug treatment (day 14±3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egg yolk antibody, Helicobacter pylori rescue therapy, Helicobacter pylori therapy