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

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

Detailed Description
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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.

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

Conditions
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Gastroesophageal Reflux Disease, GERD, Gastroesophageal Erosion, Erosive Esophagitis, Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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 may put him at risk of exacerbation of co-morbid conditions, or in cases when on discretion of the investigator patient's condition would not allow him to complete the course of the observation. These conditions include, but not limited to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe depression or other psychological disorders; the patient may stop his participation in the study at any time by informing the site personal about his/her decision to withdraw the consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: According to the initial assessment, the patients will be allocated to the following subgroups: NERD, Erosive oesophagitis, hypersensitive oesophagus. Each patient will be provided with the standard recommendations on the diet and physical activity according to the initial assessment (calculated energy expenditures, physical activity, physical status and body composition) in addition to the standard drug treatment. Repeated examinations will be performed to assess the disease status and change (if any) of diet.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Change in disease manifestations<br>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<br>* 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.<br>Behavioral: No diet adherence<br>* A-posteriori established intervention based on the examinations at the end-point<br>Behavioral: Change in physical activity<br>* The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data<br>Behavioral: No change in physical activity<br>* The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data<br>Behavioral: Use of antisecretory agents<br>* 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.<br>Behavioral: No use of antisecretory agents<br>* This intervention will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.<br>|
| Active Comparator: No change in disease flow<br>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<br>* 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.<br>Behavioral: No diet adherence<br>* A-posteriori established intervention based on the examinations at the end-point<br>Behavioral: Change in physical activity<br>* The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data<br>Behavioral: No change in physical activity<br>* The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data<br>Behavioral: Use of antisecretory agents<br>* 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.<br>Behavioral: No use of antisecretory agents<br>* This intervention will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartburn frequency | Number of days a week when the symptom is present | 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 | a day | 
| Grade of erosive oesophagitis | Grade of oesophagitis will be assessed according to the Los-Angeles classification | at the end-point, 2 years after enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, NERD, erosive esophagitis, diet, food, adherence, influence