The Effect of Lamina-G on Gastrointestinal Symptom After Gastric Biopsy

Study Overview
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Brief Summary
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Sometimes, subjects complain about gastrointestinal symptoms after esophagogastroduodenoscopy and biopsy. The aim of this study is to investigate the effect of sodium alginate (Lamina-G®) on biopsy-related gastrointestinal symptom.

Detailed Description
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This study is an open labeled, single-center randomized controlled trials. Patients who underwent upper enoscopy with biopsy were randomly assigned to medication and control group. In the medication group, sodium alginate was administered after EGD during 3 days. All patients underwent a questionnaire to check the presence of gastrointestinal symptoms at baseline and on the day after return home. After 3 days, gastrointestinal symptoms were investigated by telephone survey. Gastrointestinal symptom was scaled by upper gastrointestinal symptom rate score (GSRS). Upper GSRS contains 8 items and 3 scales; abdominal pain (abdominal pain, epigastric pain/hunger soreness, nausea), reflux symptom (Heartburn/reflux/belching gas), indigestion symptom (abdominal distension, borborygmus).

Official Title
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The Effect of 3-day Oral Administration of Lamina-G on Epigastric Pain or Soreness After Gastric Biopsy

Conditions
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Gastrointestinal Symptom

Intervention / Treatment
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* Drug: Sodium alginate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 80 years Persons who assigned on the written consent for the clinical trial. Persons who underwent upper endoscopy and gastric biopsy Exclusion Criteria: Gastrectomy Severe cardiovascular, pulmonary, or endocrine disease Renal or hepatic dysfunction Hematologic disease Gastric cancer Active peptic ulcer User of proton pump inhibitor, H2 blocker, mucoprotectant Immediate significant bleeding after biopsy Pregnant women Allergy history for sodium alginate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open labeled, single-center randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>no medication after gastric biopsy | |
| Experimental: treatment<br>oral administration of sodium alginate (LaminaG) after gastric biopsy | Drug: Sodium alginate<br>* 3 days oral administration of sodium alginate after gastric biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal symptom | Upper Gastrointestinal Symptom Rating Scale (8 domain) : score : 0,1,2,3 in each domain (0: none, 3: severe) | baseline endoscopy (T0) | 
| gastrointestinal symptom | Upper Gastrointestinal Symptom Rating Scale (8 domain) : score : 0,1,2,3 in each domain (0: none, 3: severe) | within 24 hours after endoscopy (T1) | 
| gastrointestinal symptom | Upper Gastrointestinal Symptom Rating Scale (8 domain) : score : 0,1,2,3 in each domain (0: none, 3: severe) | 3 days after endoscopy (T3) |