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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04449185

Enrollment

Registered

2020-06-26

Start date

2020-06-30

Completion date

2021-10-30

Last updated

2020-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

Dyspepsia, Microbiome, Eradication therapy

Brief summary

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

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.

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of gut microbiome	at 3 months, and 6 months	Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative

Secondary

Measure	Time frame	Description
Symptom of dyspepsia	at 3 months, and 6 months	Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
Eradication of helicobacter pylori	at 3 months	Eradication rate of helicobacter pylori at 3 months
Histologic finding of UGI tract	at initial and 3 months	Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy

Contacts

Primary ContactKee Wook Jung, MD, PhD

jung.keewook30@gmail.com821026778856

Backup ContactGa Hee Kim, MD, PhD

smallgh@hanmail.net821028732884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026