Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural a… (NCT04255693) | Clinical Trial Compass
RecruitingNot Applicable
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
Russia150 participantsStarted 2020-01-31
Plain-language summary
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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;
Exclusion Criteria:
* 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;
* severe patient's conditions which may lead to misinterpretation of data, or in case of patient's enrolment …
What they're measuring
1
Heartburn frequency
Timeframe: a week
2
Heartburn severity
Timeframe: a day
3
Grade of erosive oesophagitis
Timeframe: at the end-point, 2 years after enrolment
Trial details
NCT IDNCT04255693
SponsorFederal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology