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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

About this trial

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

Eligibility criteria

Qualifiers

willingness to participate (based on the signed informed consent form);

presence of gastroesophageal reflux disease, based on the following: a) typical symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should be present at least weekly, be actual for at least 3 months prior to the enrolment, and the patient should report the history of symptoms which lasts for at least 6 months); b) previous response to the intake of proton pump inhibitors; c) data of 24-hours oesophageal pH-impedance monitoring with detected pathological gastroesophageal reflux according to the Lyon consensus definitions;

Disqualifiers

pregnant or breast-feeding females;

abdominal or chest surgery (except appendectomy or cholecystectomy in case they are not followed by adhesive disease of the abdominal organs);

constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of NSAIDs will be allowed in case the course of treatment was discontinued at least 2 weeks prior to the enrolment, in case that constant use of NSAIDs happen to be necessary after the enrolment, the patients may continue in the study but doses, frequency and duration of treatment should be carefully documented;

history or current evidence of cancer of any aetiology and location besides skin cancer in situ successfully treated before the enrolment;

Trial design

Treatments tested in this trial

  • diet adherence
  • No diet adherence
  • Change in physical activity
  • No change in physical activity
  • Use of antisecretory agents
  • No use of antisecretory agents

Treatment groups

150 Participants
are divided into 2 treatment groups