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

Kyungpook National University

Status and phase

Completed

Phase 4

Conditions

Gastrointestinal Symptom

Treatments

Drug: Sodium alginate

Study type

Interventional

Funder types

Other

Identifiers

NCT04134364

KNUMC 2016-02-002

Details and patient eligibility

About

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.

Full description

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).

Enrollment

210 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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