GERD, GERD in Children
Conditions
Keywords
gastroesophageal reflux, weight, obesity, nutrition, GERD, esophageal pH-impedance, food frequency questionnair
Brief summary
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
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.
Interventions
OTHERdiet assessment
Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.
Sponsors
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary fibre consumption | An average of 1 year | value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day |
| Energy value of the ration | An average of 1 year | value of mean daily consumption of the energy by food frequency questionnaire, kcal/day |
| total fat consumption | An average of 1 year | value of mean daily consumption of fats by food frequency questionnaire, G/day |
| total carbohydrate consumption | An average of 1 year | value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day |
| total protein consumption | An average of 1 year | value of mean daily consumption of protein by food frequency questionnaire, G/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of gastroesophageal refluxes | 24-hours | This measure is to be obtained by 24-hours oesophageal pH-impedance study |
| Number of acid gastroesophageal refluxes | 24-hours | This measure is to be obtained by 24-hours oesophageal pH-impedance study |
| Number of weak-acid gastroesophageal refluxes | 24-hours | This measure is to be obtained by 24-hours oesophageal pH-impedance study |
| Number of high gastroesophageal refluxes | 24-hours | This measure is to be obtained by 24-hours oesophageal pH-impedance study |
| Acid exposure time | 24-hours | This measure is to be obtained by 24-hours oesophageal pH-impedance study |
Countries
Russia
Outcome results
None listed