The Study of Nutrition of Children and Adolescents With GERD

GERD Clinical Trial

Official title:

The Study of Nutrition of Children and Adolescents With GERD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202276
• Other study ID #: AAAA-?19-119041090031-7
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD
• GERD in Children

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy value of the ration	value of mean daily consumption of the energy by food frequency questionnaire, kcal/day	An average of 1 year
Primary	total fat consumption	value of mean daily consumption of fats by food frequency questionnaire, G/day	An average of 1 year
Primary	total carbohydrate consumption	value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day	An average of 1 year
Primary	total protein consumption	value of mean daily consumption of protein by food frequency questionnaire, G/day	An average of 1 year
Primary	Dietary fibre consumption	value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day	An average of 1 year
Secondary	Total number of gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Secondary	Number of acid gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Secondary	Number of weak-acid gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Secondary	Number of high gastroesophageal refluxes	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours
Secondary	Acid exposure time	This measure is to be obtained by 24-hours oesophageal pH-impedance study	24-hours

External Links

•   study data published