Helicobacter Pylori Infection Clinical Trial
Official title:
A Study on the Efficacy and Safety of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 1, 2022 |
| Est. primary completion date | December 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
| Lead Sponsor | Collaborator |
|---|---|
| The Third Xiangya Hospital of Central South University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | Adverse events | follow up to get the percentage of people with adverse reactions | After drug treatment (day 14±3) |
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