The Study of Nutrition of Children and Adolescents With GERD

Not Applicable

Completed

• Conditions: GERD; GERD in Children
• Interventions: Other: diet assessment

• Registration Number: NCT04202276
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-06-30
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patients with GERD	diet assessment	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.
Control group	diet assessment	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.

Primary Outcome Measures

Name	Time	Method
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 carbohydrate consumption	An average of 1 year	value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
total fat consumption	An average of 1 year	value of mean daily consumption of fats 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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology; 🇷🇺 Moscow, Russian Federation