Clinical trial NCT04202276: The Study of Nutrition of Children and Adolescents With GERD
Official title: The Study of Nutrition of Children and Adolescents With GERD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD in Children
GERD
Keywords: gastroesophageal reflux
weight
obesity
nutrition
GERD
esophageal pH-impedance
food frequency questionnair
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 219
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Energy value of the ration
timeFrame: An average of 1 year
measure: total fat consumption
timeFrame: An average of 1 year
measure: total carbohydrate consumption
timeFrame: An average of 1 year
measure: total protein consumption
timeFrame: An average of 1 year
measure: Dietary fibre consumption
timeFrame: An average of 1 year
Secondary outcomes:
measure: Total number of gastroesophageal refluxes
timeFrame: 24-hours
measure: Number of acid gastroesophageal refluxes
timeFrame: 24-hours
measure: Number of weak-acid gastroesophageal refluxes
timeFrame: 24-hours
measure: Number of high gastroesophageal refluxes
timeFrame: 24-hours
measure: Acid exposure time
timeFrame: 24-hours
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study officials:
affiliation: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
name: Dmitriy B Nikityuk, Professor
role: STUDY_DIRECTOR
affiliation: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
name: Tatiana Strokova, Professor
role: STUDY_CHAIR
References:
citation: Borodina G, Morozov S. Children With Gastroesophageal Reflux Disease Consume More Calories and Fat Compared to Controls of Same Weight and Age. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):808-814. doi: 10.1097/MPG.0000000000002652.