NCT04134364

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2.4 years

First QC Date

September 14, 2019

Last Update Submit

April 23, 2020

Conditions

Gastrointestinal Symptom

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

control

NO INTERVENTION

no medication after gastric biopsy

treatment

EXPERIMENTAL

oral administration of sodium alginate (LaminaG) after gastric biopsy

Drug: Sodium alginate

Interventions

Sodium alginateDRUG

3 days oral administration of sodium alginate after gastric biopsy

treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41404, South Korea

Location

MeSH Terms

Interventions

Alginates

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: open labeled, single-center randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 14, 2019

First Posted

October 22, 2019

Study Start

March 27, 2017

Primary Completion

August 23, 2019

Study Completion

September 10, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)