Clinical trial NCT04255693: Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
Official title: Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
GERD
Gastroesophageal Erosion
Erosive Esophagitis
Non-erosive Reflux Disease
Non-Erosive Gastro-Esophageal Reflux Disease
Keywords: GERD
NERD
erosive esophagitis
diet
food
adherence
influence
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heartburn frequency
timeFrame: a week
measure: Heartburn severity
timeFrame: a day
measure: Grade of erosive oesophagitis
timeFrame: at the end-point, 2 years after enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study officials:
affiliation: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
name: Sergey Morozov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
citation: Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
citation: Savarino E, Bredenoord AJ, Fox M, Pandolfino JE, Roman S, Gyawali CP; International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the physiological assessment and diagnosis of GERD. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):665-676. doi: 10.1038/nrgastro.2017.130. Epub 2017 Sep 27.
citation: Roman S, Gyawali CP, Savarino E, Yadlapati R, Zerbib F, Wu J, Vela M, Tutuian R, Tatum R, Sifrim D, Keller J, Fox M, Pandolfino JE, Bredenoord AJ; GERD consensus group. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. 2017 Oct;29(10):1-15. doi: 10.1111/nmo.13067. Epub 2017 Mar 31.
citation: Commisso A, Lim F. Lifestyle Modifications in Adults and Older Adults With Chronic Gastroesophageal Reflux Disease (GERD). Crit Care Nurs Q. 2019 Jan/Mar;42(1):64-74. doi: 10.1097/CNQ.0000000000000239.
citation: Martinucci I, Natilli M, Lorenzoni V, Pappalardo L, Monreale A, Turchetti G, Pedreschi D, Marchi S, Barale R, de Bortoli N. Gastroesophageal reflux symptoms among Italian university students: epidemiology and dietary correlates using automatically recorded transactions. BMC Gastroenterol. 2018 Jul 17;18(1):116. doi: 10.1186/s12876-018-0832-9.