Skip to main content
OpenTrials
Completed

NCT Number: NCT04202276

The Study of Nutrition of Children and Adolescents With GERD

This trial is to study the aspects of nutrition in children and adolescents with GERD compared to the sex and age-matched control group

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Moscow, 115446, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diet assessment

Other

Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.

Primary outcomes

  1. Energy value of the ration

    Time frame: An average of 1 year

    value of mean daily consumption of the energy by food frequency questionnaire, kcal/day

  2. total fat consumption

    Time frame: An average of 1 year

    value of mean daily consumption of fats by food frequency questionnaire, G/day

  3. total carbohydrate consumption

    Time frame: An average of 1 year

    value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day

  4. total protein consumption

    Time frame: An average of 1 year

    value of mean daily consumption of protein by food frequency questionnaire, G/day

  5. Dietary fibre consumption

    Time frame: An average of 1 year

    value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day

Secondary outcomes

  1. Total number of gastroesophageal refluxes

    Time frame: 24-hours

    This measure is to be obtained by 24-hours oesophageal pH-impedance study

  2. Number of acid gastroesophageal refluxes

    Time frame: 24-hours

    This measure is to be obtained by 24-hours oesophageal pH-impedance study

  3. Number of weak-acid gastroesophageal refluxes

    Time frame: 24-hours

    This measure is to be obtained by 24-hours oesophageal pH-impedance study

  4. Number of high gastroesophageal refluxes

    Time frame: 24-hours

    This measure is to be obtained by 24-hours oesophageal pH-impedance study

  5. Acid exposure time

    Time frame: 24-hours

    This measure is to be obtained by 24-hours oesophageal pH-impedance study

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Scientific Institution

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.