Helicobacter Pylori InfectionNCT05410223
Efficacy and Safety Study of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection
A study testing Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth, IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth and Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline in people with Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth, IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth and Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old, male or female;
- Patients diagnosed with Hp infection;
- Failure of Hp eradication therapy;
- Although taking acid-suppressing drugs (PPI), the drug has been stopped for more than 2 weeks;
- Those who have not used antibiotics and (or) bismuth in the past 4 weeks;
- Understand and be willing to participate in this clinical trial and provide signed informed consent.
Who cannot join
- Those with a history of allergy to drugs and egg yolk antibody products;
- Those with severe heart, liver, lung and kidney insufficiency;
- Those with a recent history of gastrointestinal bleeding, obstruction, perforation, tumor, and other serious organic diseases of the gastrointestinal tract;
- Those with mental illness or mental disorder that cannot be expressed normally;
- During the research period, those who are pregnant, breastfeeding, or have a childbearing plan recently;
- There are other persons who are not suitable for clinical trials of drugs
- No collaborators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
CANXIA XU, +8613786176248, xucanxia@163.com
About this study
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.
Read the 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
- Helicobacter Pylori Infection
- Being tested
- Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth, IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth, Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth
- Keywords
- Egg yolk antibody, Helicobacter pylori rescue therapy, Helicobacter pylori therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
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
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth Receives: Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth |
| control group | Active comparator | 14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth Receives: Drug: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth |
| the case group | Experimental | 14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline Receives: Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline |
| the control group | Active comparator | 14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth Receives: Drug: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: At four weeks after the completion of treatment (day 42±3)
Secondary outcomes (2)
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%
Measured: 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
Measured: After drug treatment (day 14±3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start6 Apr 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHA CHENG, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410223
- Sponsor's protocol ID
- xucanxia2020
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT05410223
- Acronym / sponsor ID
- xucanxia2020
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Egg yolk antibody, Helicobacter pylori rescue therapy, Helicobacter pylori therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth |
| control group | Active comparator | Drug: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth |
| the case group | Experimental | Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline |
| the control group | Active comparator | Drug: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years old, male or female;
- Patients diagnosed with Hp infection;
- Failure of Hp eradication therapy;
- Although taking acid-suppressing drugs (PPI), the drug has been stopped for more than 2 weeks;
- Those who have not used antibiotics and (or) bismuth in the past 4 weeks;
Key exclusion criteria (7 listed)
- Those with a history of allergy to drugs and egg yolk antibody products;
- Those with severe heart, liver, lung and kidney insufficiency;
- Those with a recent history of gastrointestinal bleeding, obstruction, perforation, tumor, and other serious organic diseases of the gastrointestinal tract;
- Those with mental illness or mental disorder that cannot be expressed normally;
- During the research period, those who are pregnant, breastfeeding, or have a childbearing plan recently;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, BismuthYolk 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 | study group |
| IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, BismuthIlaprazole: 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 | control group |
| Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, DoxycyclineYolk 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 | the case group |
| IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, BismuthIlaprazole: 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 | the control group |
Primary outcome
Eradication rate of Helicobacter pylori
Time frame: 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%
2 secondary outcomes
Relief of clinical symptoms (Symptom relief rate)
Time frame: After drug treatment (day 14±3) and during follow-up (day 42±3)
Adverse events
Time frame: After drug treatment (day 14±3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHA CHENG principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth, IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth and Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline in people with Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CANXIA XU (+8613786176248, xucanxia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori (time frame: At four weeks after the completion of treatment (day 42±3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.