The Study of Nutrition of Children and Adolescents With GERD
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Other: 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.
|
| Other: 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Dietary fibre consumption [An average of 1 year]
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willingness to participate (written informed consent and consent from parents or legal representative according to the local law);
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Age 6 to 17 years old inclusive,
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Possibility to assess symptoms, data of the medical history and receive answers to the questions about usual diet.
Exclusion Criteria:
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history of abdominal surgery;
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presence of varicose veins of the stomach and/or the oesophagus either in medical history or found during the study;
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inability to tolerate at least one of the invasive procedures or lacking data of the other instrumental examinations required by protocol;
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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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology | Moscow | Russian Federation | 115446 |
Sponsors and Collaborators
- Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Investigators
- Study Director: Dmitriy B Nikityuk, Professor, Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
- Study Chair: Tatiana Strokova, Professor, Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- AAAA-А19-119041090031-7