- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255693
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
August 1, 2022 updated by: Sergey Morozov, Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vasily Kropochev, MD
- Phone Number: +74997943572
- Email: followkropochev@yandex.ru
Study Locations
-
-
-
Moscow, Russian Federation, 115446
- Recruiting
- Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
-
Contact:
- Vasily Kropochev
- Phone Number: +74997943572
- Email: followkropochev@yandex.ru
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
A-posteriori established "intervention" based on the examinations at the end-point
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
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.
This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
|
Active Comparator: 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.
|
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.
A-posteriori established "intervention" based on the examinations at the end-point
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
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.
This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heartburn frequency
Time Frame: a week
|
Number of days a week when the symptom is present
|
a week
|
Heartburn severity
Time Frame: 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"
|
a day
|
Grade of erosive oesophagitis
Time Frame: at the end-point, 2 years after enrolment
|
Grade of oesophagitis will be assessed according to the Los-Angeles classification
|
at the end-point, 2 years after enrolment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sergey Morozov, MD, PhD, Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Nat Rev Gastroenterol Hepatol. 2018 Apr 06;:
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2020
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
February 2, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RLS-GERD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Deidentified individual participants data may be shared by request.
Patients personal data (name, contacts, etc) will be blinded beforehand, according to the law.
IPD Sharing Time Frame
The data will be available when the study is accomplished.
They will be available for the request for 2 years after the date of the study completion
IPD Sharing Access Criteria
By request, when the reason for IPD sharing is reasonable and clear
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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