Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
NCT ID: NCT04255693
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2020-01-31
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Dietary Patterns and Food Diversity in Russian GERD Patients
NCT04252144
Response to Supplement and Placebo in GERD
NCT01915173
Correlates of GERD Symptom Severity
NCT03020550
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
NCT00260572
Effect of MIST on Esophageal Sensitivity in Patients With rGERD
NCT05429034
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
Repeated examinations will be performed to assess the disease status and change (if any) of diet.
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Change in disease manifestations
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.
diet 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.
No diet adherence
A-posteriori established "intervention" based on the examinations at the end-point
Change in physical activity
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
No 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
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. 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.
No 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.
No change in disease flow
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.
diet 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.
No diet adherence
A-posteriori established "intervention" based on the examinations at the end-point
Change in physical activity
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
No 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
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. 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.
No 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
diet 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.
No diet adherence
A-posteriori established "intervention" based on the examinations at the end-point
Change in physical activity
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
No 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
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. 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.
No 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sergey Morozov
Leading researcher
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sergey Morozov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RLS-GERD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.