Erosive Esophagitis, Gastroesophageal Erosion, Gastroesophageal Reflux Disease, GERD, Non-Erosive Gastro-Esophageal Reflux Disease, Non-erosive Reflux Disease
Conditions
Keywords
GERD, NERD, erosive esophagitis, diet, food, adherence, influence
Brief summary
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
Detailed description
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.
Interventions
BEHAVIORALNo change in physical activity
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
BEHAVIORALdiet adherence
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.
BEHAVIORALNo diet adherence
A-posteriori established intervention based on the examinations at the end-point
BEHAVIORALChange in physical activity
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
BEHAVIORALUse of antisecretory agents
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.
BEHAVIORALNo use of antisecretory agents
This intervention will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
Sponsors
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The personnel involved to the assessment of outcomes (changes in diet, changes on endoscopy, changes on symptoms) will be blinded to the results of each other.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heartburn frequency | a week | Number of days a week when the symptom is present |
| Heartburn severity | a day | 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 |
| Grade of erosive oesophagitis | at the end-point, 2 years after enrolment | Grade of oesophagitis will be assessed according to the Los-Angeles classification |
Countries
Russia
Contacts
Primary ContactSergey Morozov, MD, PhD
Backup ContactVasily Kropochev, MD
Outcome results
None listed