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

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline; Drug: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth; Drug: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth; Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth

• Registration Number: NCT05410223
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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.

Study Timeline

• Study Start: 2021-04-06
• Status Verified: 2022-06
• Study First Submitted: 2022-06-04
• Study First Submitted QC: 2022-06-04
• Study First Posted: 2022-06-08
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the case group	Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline	14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline
control group	IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth	14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
the control group	IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth	14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
study group	Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth	14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori	At four weeks after the completion of treatment (day 42±3)	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

Name	Time	Method
Relief of clinical symptoms (Symptom relief rate)	After drug treatment (day 14±3) and during follow-up (day 42±3)	Assessment by questionnaire: Symptom relief rate = (number of people with relief of symptoms/total number of people) \*100%
Adverse events	After drug treatment (day 14±3)	follow up to get the percentage of people with adverse reactions

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China