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

Primary Purpose

Gastroesophageal Reflux Disease, GERD, Gastroesophageal Erosion

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
diet adherence
No diet adherence
Change in physical activity
No change in physical activity
Use of antisecretory agents
No use of antisecretory agents
Sponsored by
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastroesophageal Reflux Disease focused on measuring GERD, NERD, erosive esophagitis, diet, food, adherence, influence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, BiotechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Change in disease manifestations

No change in disease flow

Arm 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.

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.

Outcomes

Primary Outcome Measures

Heartburn frequency
Number of days a week when the symptom is present
Heartburn severity
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
Grade of oesophagitis will be assessed according to the Los-Angeles classification

Secondary Outcome Measures

Full Information

First Posted
February 2, 2020
Last Updated
August 1, 2022
Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
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1. Study Identification

Unique Protocol Identification Number
NCT04255693
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Change in disease manifestations
Arm Type
Experimental
Arm 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.
Arm Title
No change in disease flow
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
diet adherence
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No diet adherence
Intervention Description
A-posteriori established "intervention" based on the examinations at the end-point
Intervention Type
Behavioral
Intervention Name(s)
Change in physical activity
Intervention Description
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
Intervention Type
Behavioral
Intervention Name(s)
No change in physical activity
Intervention Description
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
Intervention Type
Behavioral
Intervention Name(s)
Use of antisecretory agents
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No use of antisecretory agents
Intervention Description
This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
Primary Outcome Measure Information:
Title
Heartburn frequency
Description
Number of days a week when the symptom is present
Time Frame
a week
Title
Heartburn severity
Description
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"
Time Frame
a day
Title
Grade of erosive oesophagitis
Description
Grade of oesophagitis will be assessed according to the Los-Angeles classification
Time Frame
at the end-point, 2 years after enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Morozov, MD, PhD
Phone
+74996131091
Email
morosoffsv@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vasily Kropochev, MD
Phone
+74997943572
Email
followkropochev@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Morozov, MD, PhD
Organizational Affiliation
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Morozov, MD, PhD
Phone
+79104681801
Email
morosoffsv@mail.ru
First Name & Middle Initial & Last Name & Degree
Vasily Kropochev
Phone
+74997943572
Email
followkropochev@yandex.ru

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://ion.ru
Citations:
PubMed Identifier
29437910
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.
Results Reference
background
PubMed Identifier
16928254
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.
Results Reference
background
PubMed Identifier
28951582
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. Erratum In: Nat Rev Gastroenterol Hepatol. 2018 Apr 06;:
Results Reference
background
PubMed Identifier
28370768
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.
Results Reference
background
PubMed Identifier
30507666
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.
Results Reference
background
PubMed Identifier
30016938
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.
Results Reference
background

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

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