Study of Dietary Patterns and Food Diversity in Russian GERD Patients

NCT ID: NCT04252144

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2023-12-31

Brief Summary

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

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.

Conditions

Gastroesophageal; Reflux With Esophagitis; Gastroesophageal Reflux; GERD; Heartburn; Non-erosive Reflux Disease; Esophagitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GERD

Patients with verified gastroesophageal reflux disease

Group Type: EXPERIMENTAL

Dietary assessment

Intervention Type: PROCEDURE

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.

Contol

Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination

Group Type: OTHER

Dietary assessment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Food frequency questionnaire

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Russian Science Foundation

OTHER

Sponsor Role: collaborator

Russian Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Vasily Isakov

MD, PhD, Professor, AGAF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vasily Isakov, MD, PhD, Professor, AGAF

Role: STUDY_CHAIR

FRC nutrition and biotechnology

Sergey Morozov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FRC Nutrition and Biotechnology

Locations

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Sergey Morozov, MD, PhD

Role: CONTACT

morosoffsv@mail.ru

+79104681801

Vasily Kropochev, MD

Role: CONTACT

followkropochev@ya.ru

+74997943572

Facility Contacts

Sergey Morozov, MD, PhD

Role: primary

84996131091@mail.ru

+74996131091

Vasily Kropochev, MD

Role: backup

followkropochev@ya.ru

+74997943572

Other Identifiers

19-76-30014 GERD

Identifier Type: -

Identifier Source: org_study_id