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Completed

NCT Number: NCT03616119

Gastroesophageal Reflux Disease in Azerbaijan

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azerbaijan Gastroenterology and hepatology Association

Baku, Nasimi, AZ1018, Azerbaijan

About this study

It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo clinic, was received and validated. The questionnaire was translated by 3 individuals from english to azeri and back trasnlated by 3 native english speakers.

Power analysis was performed. The research was presented for the approval to Ethical Committee of Azerbaijan Medical University.

Prior to the actual study, a pilot study with smaller number of participants was performed and the results were evaluated.

Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical University.

110 employees were hired for using a survey in different regions of Azerbaijan. Written consent was obtained from every person evaluated. Statistical ananlysis was performed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. The prevalence of GERD in Azerbaijan

    Time frame: 1 year

    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).

  2. GERD questionnaire (GERD) of Mayo case 1998- 019

    Time frame: 1 year

    Observational study

Sponsors and collaborators

Lead sponsor

Sevda Aghayeva

Other

Collaborators

  • Azerbaijan Medical University

Registry information

Official study title

The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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