The Study of Nutrition of Children and Adolescents With GERD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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GERD in Children GERD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patients with GERD

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.

Group Type OTHER

diet assessment

Intervention Type OTHER

Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.

Control group

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.

Group Type OTHER

diet assessment

Intervention Type OTHER

Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.

Interventions

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diet assessment

Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes