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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Apr 2021

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

April 6, 2021

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed

Last Updated

December 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

June 4, 2022

Last Update Submit

December 6, 2022

Conditions

Helicobacter Pylori Infection

Keywords

Egg yolk antibodyHelicobacter pylori rescue therapyHelicobacter pylori therapy

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Relief of clinical symptoms (Symptom relief rate)
After drug treatment (day 14±3) and during follow-up (day 42±3)
Adverse events
After drug treatment (day 14±3)

Study Arms (4)

study group

EXPERIMENTAL

14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth

control group

ACTIVE COMPARATOR

14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Drug: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth

the case group

EXPERIMENTAL

14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline

Drug: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline

the control group

ACTIVE COMPARATOR

14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth

Drug: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth

Interventions

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

study group

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

control group

Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, DoxycyclineDRUG

the case group

IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, BismuthDRUG

the control group

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

The Third Xiangya Hospital of Central South Universitylead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

AmoxicillinClarithromycinFurazolidoneDoxycyclineBismuth

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesNitrofuransNitro CompoundsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingFuransTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsElements, RadioactiveElementsInorganic ChemicalsMetals, HeavyRadioisotopesIsotopesMetals

Study Officials

SHA CHENG
The Third Xiangya Hospital of Central South University
PRINCIPAL INVESTIGATOR

Central Study Contacts

CANXIA XU

CONTACT

+8613786176248 xucanxia@163.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 8, 2022

Study Start

April 6, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

study group

control group

the case group

the control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations