The Study of Nutrition of Children and Adolescents With GERD

Study Overview
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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

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.

Official Title
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The Study of Nutrition of Children and Adolescents With GERD

Conditions
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GERD in Children, GERD

Intervention / Treatment
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* Other: diet assessment


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with GERD<br>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. | Other: diet assessment<br>* Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.<br>|
| Other: Control group<br>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. | Other: diet assessment<br>* Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy value of the ration | value of mean daily consumption of the energy by food frequency questionnaire, kcal/day | An average of 1 year | 
| total fat consumption | value of mean daily consumption of fats by food frequency questionnaire, G/day | An average of 1 year | 
| total carbohydrate consumption | value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day | An average of 1 year | 
| total protein consumption | value of mean daily consumption of protein by food frequency questionnaire, G/day | An average of 1 year | 
| Dietary fibre consumption | value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day | An average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of gastroesophageal refluxes | This measure is to be obtained by 24-hours oesophageal pH-impedance study | 24-hours | 
| Number of acid gastroesophageal refluxes | This measure is to be obtained by 24-hours oesophageal pH-impedance study | 24-hours | 
| Number of weak-acid gastroesophageal refluxes | This measure is to be obtained by 24-hours oesophageal pH-impedance study | 24-hours | 
| Number of high gastroesophageal refluxes | This measure is to be obtained by 24-hours oesophageal pH-impedance study | 24-hours | 
| Acid exposure time | This measure is to be obtained by 24-hours oesophageal pH-impedance study | 24-hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroesophageal reflux, weight, obesity, nutrition, GERD, esophageal pH-impedance, food frequency questionnair