Trials / Unknown
UnknownNCT05410223
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- The Third Xiangya Hospital of Central South University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
| 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 |
| 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. |
| 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 |
Timeline
- Start date
- 2021-04-06
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2022-06-08
- Last updated
- 2022-12-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05410223. Inclusion in this directory is not an endorsement.