Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Russian Academy of Medical Sciences (RAMS)

Status: Unknown

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

Treatments: Procedure: Dietary assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04252144

19-76-30014 GERD

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

GERD

Experimental group

Description:

Patients with verified gastroesophageal reflux disease

Treatment:

Procedure: Dietary assessment

Contol

Other group

Description:

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

Treatment:

Procedure: Dietary assessment