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Study of Dietary Patterns and Food Diversity in Russian GERD Patients

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ClinicalTrials.gov Identifier: NCT04252144
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Russian Science Foundation
Information provided by (Responsible Party):
Vasily Isakov, Russian Academy of Medical Sciences

Brief Summary:
The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients

Condition or disease Intervention/treatment Phase
Gastroesophageal; Reflux With Esophagitis Gastroesophageal Reflux GERD Heartburn Non-erosive Reflux Disease Esophagitis Procedure: Dietary assessment Not Applicable

Detailed Description:
The study of dietary patterns may provide complex vision of an association between consumption of specific foods, or groups of food products and manifestations of gastroesophageal reflux disease (symptoms: heartburn and acid regurgitation; endoscopic findings - oesophagitis). Only limited data on this matter are published to the moment and they predominantly concerns outcomes of gastroesophageal reflux disease (oesophageal adenocarcinoma or Barrett's oesophagus). Taking into the consideration that earlier studies found significant differences in consumption of nutrients in different world regions, new data on food patterns of dietary patterns in Russian GERD patients could partly fill in the gap of knowledge on this particular matter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Dietary assessment with the use of computer-based food frequency questionnaire will be performed to patients with established diagnosis of gastroesophageal reflux disease in comparison to the representatives of a control group (without the disease).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Dietary Patterns and Food Diversity in Russian GERD Patients
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: GERD
Patients with verified gastroesophageal reflux disease
Procedure: Dietary assessment
Dietary assessment is not within standards of care for patients with gastroesophageal reflux disease in Russia. Subjects enrolled to the study are to be interviewed on most common foods consumption in terms of frequency of use and sizes of portions.
Other Name: Food frequency questionnaire

Contol
Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination
Procedure: Dietary assessment
Dietary assessment is not within standards of care for patients with gastroesophageal reflux disease in Russia. Subjects enrolled to the study are to be interviewed on most common foods consumption in terms of frequency of use and sizes of portions.
Other Name: Food frequency questionnaire




Primary Outcome Measures :
  1. grains consumption diversity [ Time Frame: a month ]
    Mean number of different types of grains consumed in form of different foods or food products a month during 12-months period

  2. meat consumption diversity [ Time Frame: a month ]
    Mean number of different types of meat consumed in form of different foods or food products a month during 12-months period

  3. poultry consumption diversity [ Time Frame: a month ]
    Mean number of different types of poultry consumed in form of different foods or food products a month during 12-months period

  4. fish consumption diversity [ Time Frame: a month ]
    Mean number of different types of fish consumed in form of different foods or food products a month during 12-months period

  5. flour consumption diversity [ Time Frame: a month ]
    Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period

  6. vegetables consumption diversity [ Time Frame: a month ]
    Mean number of different types of vegetables consumed as is or in the form of different foods or food products

  7. Fruits consumption diversity [ Time Frame: a month ]
    Mean number of different types of fruits consumed as is or in the form of different foods or food products

  8. Fats consumption diversity [ Time Frame: a month ]
    Mean number of different types of fats consumed in the form of different foods or food products a month by 12 month period


Secondary Outcome Measures :
  1. GERD-associated dietary pattern [ Time Frame: a year ]
    complex of nutrients and/or foods (food products) which correlates with presence of GERD. The correlation coefficients for each food item is range in the order of significance and direction of the relationship and in accordance to the amount of the product consumed, than is formed to the integral mean.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • willingness to participate (signed the informed consent form);
  • willingness to follow all the required procedures;

Exclusion Criteria:

  • Pregnant or breast-feeding females;
  • Neoplasms, current or by the medical history (except local skin cancer successfully treated);
  • History of chest or abdominal surgery, except appendectomy and cholecistectomy (in case when no consequences of these operations like adhesive disease of the abdominal cavity are present);
  • Co-morbid conditions which can influence or mask the symptoms of GERD (including, but not limited to: ischaemic heart disease, severe pulmonary disease, severe depression or anxiety, etc);
  • the use of concomitant medications that may influence on the symptoms or other manifestations of gastroesophageal reflux disease: NSAIDs, corticosteroids (except topic ones for no longer than 2 weeks), any medications directly influencing mood and function of central nervous system (antidepressants, anxiolytics, anti-anxiety agents, anticonvulsant etc) at the moment of enrolment and during a 2 half-life period of the certain drug;
  • the use of medications that influence gastric secretion at the time of enrolment and during 2 week before it;
  • any condition of the patient which makes the participation of the patient in the study unreasonable or put him at risk of the condition's exacerbation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252144


Contacts
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Contact: Sergey Morozov, MD, PhD +79104681801 morosoffsv@mail.ru
Contact: Vasily Kropochev, MD +74997943572 followkropochev@ya.ru

Locations
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Russian Federation
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology Recruiting
Moscow, Russian Federation, 115446
Contact: Sergey Morozov, MD, PhD    +74996131091    84996131091@mail.ru   
Contact: Vasily Kropochev, MD    +74997943572    followkropochev@ya.ru   
Sponsors and Collaborators
Russian Academy of Medical Sciences
Russian Science Foundation
Investigators
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Study Chair: Vasily Isakov, MD, PhD, Professor, AGAF FRC nutrition and biotechnology
Principal Investigator: Sergey Morozov, MD, PhD FRC Nutrition and Biotechnology
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Responsible Party: Vasily Isakov, MD, PhD, Professor, AGAF, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04252144    
Other Study ID Numbers: 19-76-30014 GERD
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data may be shared by request after study completion, except subjects' personal (identification) information
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After the study completion, available for 2 years
Access Criteria: By request
URL: http://ion.ru

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vasily Isakov, Russian Academy of Medical Sciences:
food diversity
dietary pattern
healthy eating pattern
oesophagitis
GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms