Gastroesophageal Reflux Disease in Azerbaijan

Gastroesophageal Reflux Disease Clinical Trial

Official title:

The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616119
• Other study ID #: QastroHep
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2022
• Source: Azerbaijan Gastroenterology and Hepatology Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Azerbaijan	Azerbaijan Gastroenterology and hepatology Association	Baku	Nasimi

Sponsors (2)

Lead Sponsor	Collaborator
Sevda Aghayeva	Azerbaijan Medical University

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	GERD questionnaire (GERD) of Mayo case 1998- 019	Observational study	1 year