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

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Status: Enrolling

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

Treatments: Behavioral: No change in physical activity; Behavioral: No diet adherence; Behavioral: Change in physical activity; Behavioral: Use of antisecretory agents; Behavioral: No use of antisecretory agents; Behavioral: diet adherence

Study type: Interventional

Funder types: Other

Identifiers

NCT04255693

RLS-GERD

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Change in disease manifestations

Experimental group

Description:

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.

Treatment:

Behavioral: No use of antisecretory agents

Behavioral: No diet adherence

Behavioral: diet adherence

Behavioral: Use of antisecretory agents

Behavioral: No change in physical activity

Behavioral: Change in physical activity

No change in disease flow

Active Comparator group

Description:

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.

Treatment:

Behavioral: No use of antisecretory agents

Behavioral: No diet adherence

Behavioral: diet adherence

Behavioral: Use of antisecretory agents

Behavioral: No change in physical activity

Behavioral: Change in physical activity