Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

NCT ID: NCT04449185

Last Updated: 2020-06-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyspepsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HP eradication group

HP eradication group

Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Group Type EXPERIMENTAL

Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Intervention Type DRUG

Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who has diagnosed with functional dyspesia by Rome IV criteria

Exclusion Criteria

* Known GI malignancy
* Previous Helicobater pylori eradication history
* Severe systemic disease
* Previous GI surgery
* Uncorrectable coagulopathy: INR \> 1.5 or platelet \< 50,000/ml
* Pregnant or breastfeeding women
* Atrophic gastritis, open type
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kee Wook Jung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kee Wook Jung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kee Wook Jung, MD, PhD

Role: CONTACT

821026778856

Ga Hee Kim, MD, PhD

Role: CONTACT

821028732884

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-0621

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tradipitant for Functional Dyspepsia
NCT05653310 ENROLLING_BY_INVITATION PHASE2