An interventional study of diet adherence and No diet adherence in Gastroesophageal Reflux Disease, GERD and Gastroesophageal Erosion, sponsored by Federal State Budgetary Scientific Institution. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Federal State Budgetary Scientific Institution · Not applicable, Interventional, and Other
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
The role of diet in the treatment of gastroesophageal reflux disease (GERD) is still under discussion. Some studies support the evidence that specific components of food plays a role in triggering symptoms or may have an impact on reflux oesophagitis. Still, only limited data are present on the long-term real-life effects of diet and behaviour on the disease manifestations and outcomes. This specific study aims to investigate the role of diet in real-life cohort of patients in whom diagnosis of GERD is initially confirmed with the use of modern techniques (questionnaires, endoscopy, oesophageal pH-impedance recordings). To make the study possible, it is planned to form a cohort of patients with different manifestations of gastroesophageal reflux disease: non-erosive GERD (NERD), reflux-oesophagitis (EE), hypersensitive oesophagus. Each form of GERD is to be established in accordance to modern concept of GERD (i.e. Lyon consensus). In addition to standard-of-care examinations, diet assessment will be performed with the use of computer-based food frequency questionnaire (FFQ), which allows to analyse frequently used foods, food products in terms of frequency of consumption and sizes of the portions. Assessment of diet will be performed at the enrolment and than with a period of three months during three years. Based on the results, it would be possible to assess the effect of long-term adherence to diet, change of the composition of it, and perform a multifactorial statistical analysis with the consideration of other confounders: change in BMI, physical activity, smoking, concomitant medications, etc.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Federal State Budgetary Scientific Institution is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: diet adherence · Behavioral: No diet adherence · Behavioral: Change in physical activity · Behavioral: No change in physical activity · Behavioral: Use of antisecretory agents · Behavioral: No use of antisecretory agents
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.
Behavioral: diet adherence · Behavioral: No diet adherence · Behavioral: Change in physical activity · Behavioral: No change in physical activity · Behavioral: Use of antisecretory agents · Behavioral: No use of antisecretory agents
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.
A-posteriori established "intervention" based on the examinations at the end-point
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
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.
This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
Heartburn frequency
Number of days a week when the symptom is present
Time frame: a week
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
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
Plan to share: Yes — Deidentified individual participants data may be shared by request. Patients personal data (name, contacts, etc) will be blinded beforehand, according to the law.
Supporting information: Study protocol, Sap, Csr, Analytic code
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Federal State Budgetary Scientific Institution