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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | no medication after gastric biopsy | |
| treatment | Experimental | oral administration of sodium alginate (LaminaG) after gastric biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium alginate | Drug | 3 days oral administration of sodium alginate after gastric biopsy |
|
| 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) |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 41404 | South Korea |
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| ID | Term |
|---|---|
| D000464 | Alginates |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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open labeled, single-center randomized controlled trial
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