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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Russian Federation
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
RECRUITING
Moscow
Contact Information
Primary
Sergey Morozov, MD, PhD
morosoffsv@mail.ru
+74996131091
Backup
Vasily Kropochev, MD
followkropochev@yandex.ru
+74997943572
Time Frame
Start Date: 2020-01-31
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Change in disease manifestations
The data of all the patients will be assessed from the viewpoint of changes in the disease flow (severity and frequency of symptoms, grade of oesophagitis). They will be compared to the changes of the major factors that could influence the disease flow: adherence to anti-secretory agents, presence of concomitant medications and their doses, adherence to diet, change in physical activity. These will be compared to the initial data. Thus, it would be possible to make a multivariate comparison and try to establish the influence (and, possibly, weight) of each of the con-founder on the disease flow.
Active_comparator: No change in disease flow
To this arm patients with no change in the disease manifestations will be assigned, based on the end-point evaluation. The same as in the experimental groups factors will be analysed to establish the difference.
Sponsors
Leads: Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology

This content was sourced from clinicaltrials.gov