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

Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

  lead OTHER

Principal Investigators

• Sergey Morozov, MD, PhD · Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-31

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Russia

Study Locations