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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Symptom
• Intervention / Treatment: Drug: Sodium alginate

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): September 10, 2019

Study Registration Dates

• First Submitted: September 14, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: KNUMC 2016-02-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No