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

Study Overview

• Status: Completed
• Conditions: GERD; GERD in Children
• Intervention / Treatment: Other: diet assessment

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 Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy value of the ration	value of mean daily consumption of the energy by food frequency questionnaire, kcal/day	An average of 1 year
total fat consumption	value of mean daily consumption of fats by food frequency questionnaire, G/day	An average of 1 year
total carbohydrate consumption	value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day	An average of 1 year
total protein consumption	value of mean daily consumption of protein by food frequency questionnaire, G/day	An average of 1 year
Dietary fibre consumption	value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day	An average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Number of acid gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Number of weak-acid gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Number of high gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Acid exposure time	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• study data published

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (ACTUAL): December 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: GERD; obesity; nutrition; gastroesophageal reflux; weight; esophageal pH-impedance; food frequency questionnair
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: AAAA-А19-119041090031-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be shared by the request. No personal data of the participants is a subject for sharing.
• IPD Sharing Time Frame: upon study completion. Available for 2 years according to the local low
• IPD Sharing Access Criteria: by request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No