Clinical trial NCT05410223: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Egg yolk antibody
Helicobacter pylori rescue therapy
Helicobacter pylori therapy
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: At four weeks after the completion of treatment (day 42±3)
Secondary outcomes:
measure: Relief of clinical symptoms (Symptom relief rate)
timeFrame: After drug treatment (day 14±3) and during follow-up (day 42±3)
measure: Adverse events
timeFrame: After drug treatment (day 14±3)
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: SHA CHENG
role: PRINCIPAL_INVESTIGATOR
References: