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

The Third Xiangya Hospital of Central South University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Interventions

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

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

IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, BismuthDRUG

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

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

IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, BismuthDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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%

Time frame: At four weeks after the completion of treatment (day 42±3)

Secondary Outcomes

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%

Time frame: 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

Time frame: After drug treatment (day 14±3)