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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • diet adherence

    Behavioral

    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.

  • No diet adherence

    Behavioral

    A-posteriori established "intervention" based on the examinations at the end-point

  • Change in physical activity

    Behavioral

    The 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

    Behavioral

    The 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

    Behavioral

    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.

  • No use of antisecretory agents

    Behavioral

    This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Change in disease manifestationsExperimental treatment 6 interventions
Group B: No change in disease flowActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Heartburn frequency

Number of days a week when the symptom is present

Time frame
a week
2

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"

Time frame
a day
3

Grade of erosive oesophagitis

Grade of oesophagitis will be assessed according to the Los-Angeles classification

Time frame
at the end-point, 2 years after enrolment

Secondary outcomes

Other outcomes

Sponsors and contacts

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