Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
ID06561698

High-dose Dual Therapy and Minocycline-containing Quadruple Therapy for Helicobacter pylori Infection

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-12-30

200

Participants Needed

10

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate and compare treatments for people infected with Helicobacter pylori, a type of bacteria that can cause stomach problems. It is a Phase 4 multicenter prospective study including 200 patients confirmed positive for H. pylori by rapid urease test or 13C urea breath test. The study will follow ethical guidelines and obtain informed consent from all participants before enrollment. Researchers will assess factors such as antibiotic resistance, success rates, adverse reactions, and patient compliance during treatment. Participants will receive either a high-dose dual therapy or a quadruple therapy containing minocycline and other medications. The drugs studied include vonoprazan (a potassium competitive acid blocker), amoxicillin, bismuth potassium citrate (which protects the stomach lining and fights H. pylori), and a combination of minocycline and metronidazole antibiotics. All patients will undergo H. pylori culture and drug sensitivity testing to guide therapy. During the study, researchers will monitor the eradication rate of H. pylori six weeks after therapy completion. They will also observe adverse reactions and patient adherence to treatment. The study includes careful follow-up and assessments to measure treatment outcomes and antibiotic resistance impact. The total participation period and further follow-up details are guided by study protocols to ensure comprehensive evaluation of therapies.

CONDITIONS

Official Title

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed Helicobacter pylori infection
  • Age between 18 and 70 years
Not Eligible

You will not qualify if you...

  • Pregnant and lactating women
  • History of gastrointestinal cancers
  • Previous subtotal gastrectomy
  • Serious dysfunction of heart, liver, kidney, lung, or other important organs or congenital diseases such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease
  • History of blood diseases
  • Allergy to study drugs
  • Refusal by patient or guardian to participate
  • Alcohol or drug abuse or poor treatment compliance
  • No legal capacity or poor self-knowledge
  • Use of antibiotics, bismuth, antisecretory drugs, or Chinese herbal medicine within 8 weeks before the study

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Hebi People's Hospital

Hebi, Henan, China

Actively Recruiting

2

Jiaozuo People's Hospital

Jiaozuo, Henan, China

Actively Recruiting

3

Luoyang central Hospital

Luoyang, Henan, China

Actively Recruiting

4

The first people's hospital of ping ding shan

Pingdingshan, Henan, China

Actively Recruiting

5

Xuchang central Hospital

Xuchang, Henan, China

Actively Recruiting

6

The Second Affiliated Hospital of Henan University of science and technology

Zhengzhou, Henan, China

Actively Recruiting

7

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Actively Recruiting

8

Zhengzhou People's Hospital

Zhengzhou, Henan, China

Actively Recruiting

9

Zhoukou Central Hospital

Zhoukou, Henan, China

Actively Recruiting

10

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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High-dose Dual Therapy and Minocycline-containing Quadruple Therapy for Helicobacter pylori Infection | DecenTrialz