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The Study of Nutrition of Children and Adolescents With GERD

Primary Purpose

GERD in Children, GERD

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
diet assessment
Sponsored by
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for GERD in Children focused on measuring gastroesophageal reflux, weight, obesity, nutrition, GERD, esophageal pH-impedance, food frequency questionnair

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with GERD

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Energy value of the ration
value of mean daily consumption of the energy by food frequency questionnaire, kcal/day
total fat consumption
value of mean daily consumption of fats by food frequency questionnaire, G/day
total carbohydrate consumption
value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
total protein consumption
value of mean daily consumption of protein by food frequency questionnaire, G/day
Dietary fibre consumption
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2019
Last Updated
January 25, 2022
Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
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1. Study Identification

Unique Protocol Identification Number
NCT04202276
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD in Children, GERD
Keywords
gastroesophageal reflux, weight, obesity, nutrition, GERD, esophageal pH-impedance, food frequency questionnair

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with GERD
Arm Type
Other
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
diet assessment
Intervention Description
Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.
Primary Outcome Measure Information:
Title
Energy value of the ration
Description
value of mean daily consumption of the energy by food frequency questionnaire, kcal/day
Time Frame
An average of 1 year
Title
total fat consumption
Description
value of mean daily consumption of fats by food frequency questionnaire, G/day
Time Frame
An average of 1 year
Title
total carbohydrate consumption
Description
value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
Time Frame
An average of 1 year
Title
total protein consumption
Description
value of mean daily consumption of protein by food frequency questionnaire, G/day
Time Frame
An average of 1 year
Title
Dietary fibre consumption
Description
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day
Time Frame
An average of 1 year
Secondary Outcome Measure Information:
Title
Total number of gastroesophageal refluxes
Description
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Time Frame
24-hours
Title
Number of acid gastroesophageal refluxes
Description
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Time Frame
24-hours
Title
Number of weak-acid gastroesophageal refluxes
Description
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Time Frame
24-hours
Title
Number of high gastroesophageal refluxes
Description
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Time Frame
24-hours
Title
Acid exposure time
Description
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Time Frame
24-hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitriy B Nikityuk, Professor
Organizational Affiliation
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tatiana Strokova, Professor
Organizational Affiliation
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Official's Role
Study Chair
Facility Information:
Facility Name
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://rosrid.ru
Citations:
PubMed Identifier
32443037
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.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1097/MPG.0000000000002652
Description
study data published

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The Study of Nutrition of Children and Adolescents With GERD

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