Differences in the Eradication of Helicobacter Pylori by Different Therapies

NCT ID: NCT05097846

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2022-10-17

Brief Summary

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To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.

Detailed Description

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A single-center, prospective, open-label, parallel control design was conducted to enroll 100 patients with confirmed Helicobacter pylori infection. Patients were randomly divided into four groups, respectively accept four treatment regimens including (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline. The effectiveness, safety and compliance of the four regimens were compared, and the cost-benefit analysis of the different regimens was conducted. The purpose of this study was to explore the most appropriate treatment plan for radical treatment of Helicobacter pylori .

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1: Vonoprazan Fumarate + amoxicillin + doxycycline

Group Type EXPERIMENTAL

Group1 Vonoprazan Fumarate + amoxicillin + doxycycline

Intervention Type DRUG

Vonoprazan Fumarate + amoxicillin + doxycycline

Group2: Vonoprazan Fumarate + furazolidone + doxycycline

Group Type EXPERIMENTAL

Group2 Vonoprazan Fumarate + furazolidone + doxycycline

Intervention Type DRUG

Vonoprazan Fumarate + furazolidone + doxycycline

Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Group Type EXPERIMENTAL

Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Intervention Type DRUG

esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

Group Type EXPERIMENTAL

Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

Intervention Type DRUG

esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

Interventions

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Group1 Vonoprazan Fumarate + amoxicillin + doxycycline

Vonoprazan Fumarate + amoxicillin + doxycycline

Intervention Type DRUG

Group2 Vonoprazan Fumarate + furazolidone + doxycycline

Vonoprazan Fumarate + furazolidone + doxycycline

Intervention Type DRUG

Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Intervention Type DRUG

Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years, ≤80 years
2. Urea breath test (UBT) was positive for Hp infection;
3. WIthout any anti-Hp treatment before
4. Endoscopy was performed within 1 month
5. Understanding the purpose and procedure of the study, voluntarily participating in the study and signing a written informed consent.

Exclusion Criteria

1. Allergic to drugs used in this clinical study;
2. Using PPI, histamine H2 receptor antagonist, antibiotics, bismuth, probiotics or drugs with antibacterial effects within 4 weeks before treatment.
3. Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs and anticoagulants
4. The disease or clinical condition that may interfere with the treatment evaluation of the study, such as liver disease, cardiovascular disease, lung disease, kidney disease, metabolic disease, psychiatric disease, or malignant tumor
5. Pregnant or lactating women
6. Participated in other clinical studies within 3 months prior to the registration of this clinical study
7. Suspected history of antibiotic abuse
8. Patients with craniocerebral injury, mental illness or epilepsy who cannot communicate with others or other diseases that may affect follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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wang xiaoyan

OTHER

Sponsor Role lead

Responsible Party

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wang xiaoyan

Director, Head of Gastroenterology, Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The third Xiangya Hospital of central south University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyan Wang, MD,PhD

Role: CONTACT

+8613974889301

Zinan Zhang, MD

Role: CONTACT

+8615273169959

Facility Contacts

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Xiaoyan Wang, MD

Role: primary

+8613974889301

Zinan Zhang, MD

Role: backup

+8615273169959

References

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Zhang Z, Liu F, Ai F, Chen X, Liu R, Zhang C, Fang N, Fu T, Wang X, Tang A. The efficacy and mechanism of vonoprazan-containing triple therapy in the eradication of Helicobacter pylori. Front Pharmacol. 2023 May 5;14:1143969. doi: 10.3389/fphar.2023.1143969. eCollection 2023.

Reference Type DERIVED
PMID: 37214450 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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2021HP

Identifier Type: -

Identifier Source: org_study_id

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