GERD in ChildrenNCT04202276
The Study of Nutrition of Children and Adolescents With GERD
A study testing diet assessment in people with GERD in Children and GERD, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD in Children, GERD
- What is being tested?
- diet assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446
About this study
This trial is to study the aspects of nutrition in children and adolescents with GERD compared to the sex and age-matched control group
Read the 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.
- Conditions
- GERD in Children, GERD
- Being tested
- diet assessment
- Keywords
- gastroesophageal reflux, weight, obesity, nutrition, GERD, esophageal pH-impedance, food frequency questionnair
- Medical subject headings
- Gastroesophageal Reflux, Body Weight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet assessmentOther
Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.
| Study group | Role | What they receive |
|---|---|---|
| Patients with GERD | Other | 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. Receives: Other: diet assessment |
| Control group | Other | 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. Receives: Other: diet assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy value of the ration
value of mean daily consumption of the energy by food frequency questionnaire, kcal/day
Measured: An average of 1 year
total fat consumption
value of mean daily consumption of fats by food frequency questionnaire, G/day
Measured: An average of 1 year
total carbohydrate consumption
value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
Measured: An average of 1 year
total protein consumption
value of mean daily consumption of protein by food frequency questionnaire, G/day
Measured: An average of 1 year
Dietary fibre consumption
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day
Measured: An average of 1 year
Secondary outcomes (5)
Total number of gastroesophageal refluxes
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Measured: 24-hours
Number of acid gastroesophageal refluxes
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Measured: 24-hours
Number of weak-acid gastroesophageal refluxes
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Measured: 24-hours
Number of high gastroesophageal refluxes
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Measured: 24-hours
Acid exposure time
This measure is to be obtained by 24-hours oesophageal pH-impedance study
Measured: 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jan 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERD in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sergey Morozov, Federal State Budgetary Scientific Institution
- Investigators
- Dmitriy B Nikityuk, Professor, Study director, Federal State Budgetary Scientific InstitutionTatiana Strokova, Professor, Study chair, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202276
- Sponsor's protocol ID
- AAAA-А19-119041090031-7
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared by the request. No personal data of the participants is a subject for sharing.
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.
PubMed 32443037
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Nutrition of Children and Adolescents With GERD
- ClinicalTrials.gov ID
- NCT04202276
- Acronym / sponsor ID
- AAAA-А19-119041090031-7
- Conditions
- GERD in Children, GERD
- Keywords
- gastroesophageal reflux, weight, obesity, nutrition, GERD, esophageal pH-impedance, food frequency questionnair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with GERD | Other | Other: diet assessmentThe data of Food frequency questionnaire (FFQ), 24-hours oesophageal pH-impedance examination, GERD-Q questionnaire to be performed in children and adolescents with GERD. |
| Control group | Other | Other: diet assessmentThe 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet assessmentFood 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, Patients with GERD |
Primary outcome
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
total fat consumption
Time frame: An average of 1 year
value of mean daily consumption of fats by food frequency questionnaire, G/day
total carbohydrate consumption
Time frame: An average of 1 year
value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
total protein consumption
Time frame: An average of 1 year
value of mean daily consumption of protein by food frequency questionnaire, G/day
Dietary fibre consumption
Time frame: An average of 1 year
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day
5 secondary outcomes
Total number of gastroesophageal refluxes
Time frame: 24-hours
Number of acid gastroesophageal refluxes
Time frame: 24-hours
Number of weak-acid gastroesophageal refluxes
Time frame: 24-hours
Number of high gastroesophageal refluxes
Time frame: 24-hours
Acid exposure time
Time frame: 24-hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 32443037Borodina 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.
- Individual participant dataSharing planned: Yes. Data may be shared by the request. No personal data of the participants is a subject for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitriy B Nikityuk, Professor study director
Federal State Budgetary Scientific Institution
Tatiana Strokova, Professor study chair
Federal State Budgetary Scientific Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet assessment in people with GERD in Children and GERD, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy value of the ration (time frame: An average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.