The Study of Nutrition of Children and Adolescents With GERD

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

Status: Completed

Conditions: GERD in Children; GERD

Treatments: Other: diet assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04202276

AAAA-А19-119041090031-7

Details and patient eligibility

About

This trial is to study the aspects of nutrition in children and adolescents with GERD compared to the sex and age-matched control group

Full description

The aim of the study is to assess the differences in nutrition of pediatric patients with GERD compared to the control group. The secondary aim is to study possible associations of the data on nutritional habits revealed with the use of food frequency questionnaire (FFQ) and the data of 24-hours oesophageal pH-impedance examination.

Enrollment: 219 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willingness to participate (written informed consent and consent from parents or legal representative according to the local law);
• Age 6 to 17 years old inclusive,
• Possibility to assess symptoms, data of the medical history and receive answers to the questions about usual diet.

Exclusion criteria

• history of abdominal surgery;
• presence of varicose veins of the stomach and/or the oesophagus either in medical history or found during the study;
• inability to tolerate at least one of the invasive procedures or lacking data of the other instrumental examinations required by protocol;
• general condition of the patient making impossible to perform all the examinations or when performing the procedures is not safe and reasonable based on the opinion of the investigator that it may exacerbate the disease flow or put the patient at risk;
• intake of medications which may influence the clinical and instrumental data, including, but not limited to: non-steroid anti-inflammatory agents, glucocorticosteroids (except for skin products, if they were used for 2 weeks or less at the time of inclusion into the study), medications affecting adrenergic, acetylcholine receptors, antidepressants, tranquillizers, sedatives, those with known local irritant effect on the gastrointestinal tract mucosa; the use of proton pump inhibitors and H2 receptors blockers are not allowed during the study, a wash-out period for at least 2 weeks is necessary before the enrolment.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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219 participants in 2 patient groups

Patients with GERD

Other group

Description:

The data of Food frequency questionnaire (FFQ), 24-hours oesophageal pH-impedance examination, GERD-Q questionnaire to be performed in children and adolescents with GERD.

Treatment:

Other: diet assessment

Control group

Other group

Description:

The same examinations as in experimental group are to be performed in patients of the control group (no GERD according to the results of the examination): Food frequency questionnaire (FFQ), 24-hours oesophageal pH-impedance examination, GERD-Q questionnaire.

Treatment:

Other: diet assessment