About this trial
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
diet adherence
BehavioralThis 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.
No diet adherence
BehavioralA-posteriori established "intervention" based on the examinations at the end-point
Change in physical activity
BehavioralThe changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
No change in physical activity
BehavioralThe changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
Use of antisecretory agents
BehavioralThis "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.
No use of antisecretory agents
BehavioralThis "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
Treatment groups
Trial outcomes
Primary outcomes
Heartburn frequency
Number of days a week when the symptom is present
Heartburn severity
Subjective description reported by the patient, assessed with the use of visual analogue scale, from 0 to 5, where 0 is "not at all severe" and 5 is "very severe"
Grade of erosive oesophagitis
Grade of oesophagitis will be assessed according to the Los-Angeles classification
Sponsors and contacts
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