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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

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

NCT ID

NCT04255693

First Posted

February 2, 2020

Last Updated

August 1, 2022

Sponsor

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

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

No change in disease flow

Arm Type

Active Comparator

Arm Description

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

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

morosoffsv@mail.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Vasily Kropochev, MD

Phone

+74997943572

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

morosoffsv@mail.ru

First Name & Middle Initial & Last Name & Degree

Vasily Kropochev

Phone

+74997943572

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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