NCT04255693

Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease

Detailed description

The role of diet in the treatment of gastroesophageal reflux disease (GERD) is still under discussion. Some studies support the evidence that specific components of food plays a role in triggering symptoms or may have an impact on reflux oesophagitis. Still, only limited data are present on the long-term real-life effects of diet and behaviour on the disease manifestations and outcomes. This specific study aims to investigate the role of diet in real-life cohort of patients in whom diagnosis of GERD is initially confirmed with the use of modern techniques (questionnaires, endoscopy, oesophageal pH-impedance recordings). To make the study possible, it is planned to form a cohort of patients with different manifestations of gastroesophageal reflux disease: non-erosive GERD (NERD), reflux-oesophagitis (EE), hypersensitive oesophagus. Each form of GERD is to be established in accordance to modern concept of GERD (i.e. Lyon consensus). In addition to standard-of-care examinations, diet assessment will be performed with the use of computer-based food frequency questionnaire (FFQ), which allows to analyse frequently used foods, food products in terms of frequency of consumption and sizes of the portions. Assessment of diet will be performed at the enrolment and than with a period of three months during three years. Based on the results, it would be possible to assess the effect of long-term adherence to diet, change of the composition of it, and perform a multifactorial statistical analysis with the consideration of other confounders: change in BMI, physical activity, smoking, concomitant medications, etc.

Conditions

• Gastroesophageal Reflux Disease
• GERD
• Gastroesophageal Erosion
• Erosive Esophagitis
• Non-erosive Reflux Disease
• Non-Erosive Gastro-Esophageal Reflux Disease

Interventions

Type	Name	Description
BEHAVIORAL	diet adherence	This type of "intervention" is to be established in a-posteriori analysis by the assessment of a fact whether a subject kept to use his "usual" diet or it contained substantial changes.
BEHAVIORAL	No diet adherence	A-posteriori established "intervention" based on the examinations at the end-point
BEHAVIORAL	Change in physical activity	The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
BEHAVIORAL	No change in physical activity	The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
BEHAVIORAL	Use of antisecretory agents	This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data. The need for the use of anti-secretory agents depends on the form of GERD and will be on the treating physician discretion. It is principal to account the use of anti-secretory agents (H2-histamine receptors blockers, proton pump inhibitors) as a major factors that may influence the outcomes.
BEHAVIORAL	No use of antisecretory agents	This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.

Timeline

• Start date: 2020-01-31
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-02-05
• Last updated: 2025-08-03

Locations

1 site across 1 country: Russia