NCT04289519

Brief Summary

Gastritis defines any (histologically confirmed) inflammation of the gastric mucosa

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 23, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

September 23, 2019

Last Update Submit

February 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • causes of gastritis in children as shown by upper endoscopy

    * infections * inflammation * Helicobacter pylori * Acute erosive gastritis

    average 1 year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy

You may qualify if:

  • All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy

You may not qualify if:

  • All children underwent upper endoscopy during the study period not diagnosed as gastritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Pasechnikov VD, Chukov SZ, Kotelevets SM, Mostovov AN, Mernova VP, Polyakova MB. Invasive and non-invasive diagnosis of Helicobacter pylori-associated atrophic gastritis: a comparative study. Scand J Gastroenterol. 2005 Mar;40(3):297-301. doi: 10.1080/00365520410010607.

    PMID: 15932170BACKGROUND
  • Kusters JG, van Vliet AH, Kuipers EJ. Pathogenesis of Helicobacter pylori infection. Clin Microbiol Rev. 2006 Jul;19(3):449-90. doi: 10.1128/CMR.00054-05.

    PMID: 16847081BACKGROUND
  • Gold BD, Colletti RB, Abbott M, Czinn SJ, Elitsur Y, Hassall E, Macarthur C, Snyder J, Sherman PM; North American Society for Pediatric Gastroenterology and Nutrition. Helicobacter pylori infection in children: recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr. 2000 Nov;31(5):490-7. doi: 10.1097/00005176-200011000-00007. No abstract available.

    PMID: 11144432BACKGROUND
  • Tam YH, Chan KW, To KF, Cheung ST, Mou JW, Pang KK, Wong YS, Sihoe JD, Lee KH. Impact of pediatric Rome III criteria of functional dyspepsia on the diagnostic yield of upper endoscopy and predictors for a positive endoscopic finding. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):387-91. doi: 10.1097/MPG.0b013e31820e2026.

    PMID: 21415670BACKGROUND
  • Glickman JN, Antonioli DA. Gastritis. Gastrointest Endosc Clin N Am. 2001 Oct;11(4):717-40, vii.

    PMID: 11689363BACKGROUND
  • Kayacetin S, Guresci S. What is gastritis? What is gastropathy? How is it classified? Turk J Gastroenterol. 2014 Jun;25(3):233-47. doi: 10.5152/tjg.2014.7906.

    PMID: 25141310BACKGROUND

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Central Study Contacts

Naglaa Hassan, Professor

CONTACT

Amira Mohamed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 23, 2019

First Posted

February 28, 2020

Study Start

September 30, 2020

Primary Completion

October 30, 2020

Study Completion

April 30, 2021

Last Updated

February 28, 2020

Record last verified: 2020-02