Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications

Study Overview
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Brief Summary
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Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Detailed Description
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Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The common adverse events related to the eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting, diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to reduce or prevent the adverse events related to the eradication medications. However, there is no established methods to reduce or prevent these events. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Official Title
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Additive Effect of Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications; an Open-label, Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Trimebutine 100 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who underwent upper gastrointestinal endoscopy and were proven to have H. pylori infection either by using the rapid urease test, the 13 C-urea breath test (UBT), or histological examination. Exclusion Criteria: Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist and antibiotics, Subjects who underwent stomach resection Subjects less than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trimebutine add group<br>Addition of Trimebutine on the Bismuth-containing quadruple regimen | Drug: Trimebutine 100 MG<br>* Trimebutine 100mg three times a day<br>* Other names: Polybutine (Samil Pharm.Co.,Ltd.);|
| No Intervention: Control group<br>Bismuth-containing quadruple regimen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall compliance of eradication medication | How much the enrolled subjects took prescribed eradication medication | 2 weeks after prescription of eradication medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to eradication medication | percentage of Adverse events related to eradication medication | 2 weeks and 6 weeks after prescription of eradication medication |