NCT03616119

Brief Summary

To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

July 29, 2018

Last Update Submit

December 11, 2022

Conditions

Keywords

gastoesophageal reflux diseaseprevalenceAzerbaijan

Outcome Measures

Primary Outcomes (2)

  • The prevalence of GERD in Azerbaijan

    The prevalence of GERD in Azerbaijan was 22.7% with significant female predominance (26.1% vs 15.3%; p\<0.0001). GERD was defined in 17 % for ages below 35; 22.7 % for 36-55 and 38.5 % for those who are above 56 that, accordingly, indicating that GERD becomes significant as age increases (p\<0.0001). Reflux was observed in 18.1% of normal weight respondents (BMI 18.6-24.9), 25.6% of overweight (BMI 25-29.9), and in 30.4% of obese (BMI\>30) individuals (p=0.001). Regarding marital status, the prevalence was the lowest in the single subjects' group (17%), close to average in the married group (23.8%), and the highest (41.7%) in divorced/widowed cases (p=0.003). Stress was significantly affecting GERD distribution, affecting 59.4% of all respondents (p\<0.004).

    1 year

  • GERD questionnaire (GERD) of Mayo case 1998- 019

    Observational study

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-80 age range
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on reflux disease in the given age range and calculated by proportion of males and females.

You may qualify if:

  • Age: 18-80
  • Both genders
  • Hearburn
  • Belching
  • Regurgitation

You may not qualify if:

  • protom pomp inhibitor use
  • antibiotic use in the last 4 weeks
  • upper GI surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azerbaijan Gastroenterology and hepatology Association

Baku, Nasimi, AZ1018, Azerbaijan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Sevda Aghayeva, MD

    Azerbaijan Gastroenterology and Hepatology Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 29, 2018

First Posted

August 6, 2018

Study Start

January 1, 2018

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations