Gastroesophageal; Reflux With EsophagitisNCT04252144
Study of Dietary Patterns and Food Diversity in Russian GERD Patients
A study testing Dietary assessment in people with Gastroesophageal; Reflux With Esophagitis and Gastroesophageal Reflux, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal; Reflux With Esophagitis, Gastroesophageal Reflux, GERD
- What is being tested?
- Dietary assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jan 2020to 31 Dec 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willingness to participate (signed the informed consent form);
- willingness to follow all the required procedures;
Who cannot join
- Pregnant or breast-feeding females;
- Neoplasms, current or by the medical history (except local skin cancer successfully treated);
- History of chest or abdominal surgery, except appendectomy and cholecistectomy (in case when no consequences of these operations like adhesive disease of the abdominal cavity are present);
- Co-morbid conditions which can influence or mask the symptoms of GERD (including, but not limited to: ischaemic heart disease, severe pulmonary disease, severe depression or anxiety, etc);
- the use of concomitant medications that may influence on the symptoms or other manifestations of gastroesophageal reflux disease: NSAIDs, corticosteroids (except topic ones for no longer than 2 weeks), any medications directly influencing mood and function of central nervous system (antidepressants, anxiolytics, anti-anxiety agents, anticonvulsant etc) at the moment of enrolment and during a 2 half-life period of the certain drug;
- the use of medications that influence gastric secretion at the time of enrolment and during 2 week before it;
- any condition of the patient which makes the participation of the patient in the study unreasonable or put him at risk of the condition's exacerbation
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Moscow, 115446
Sergey Morozov, MD, PhD, +74996131091, 84996131091@mail.ru
Vasily Kropochev, MD, +74997943572, followkropochev@ya.ru
About this study
The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients
Read the detailed description
The study of dietary patterns may provide complex vision of an association between consumption of specific foods, or groups of food products and manifestations of gastroesophageal reflux disease (symptoms: heartburn and acid regurgitation; endoscopic findings - oesophagitis). Only limited data on this matter are published to the moment and they predominantly concerns outcomes of gastroesophageal reflux disease (oesophageal adenocarcinoma or Barrett's oesophagus). Taking into the consideration that earlier studies found significant differences in consumption of nutrients in different world regions, new data on food patterns of dietary patterns in Russian GERD patients could partly fill in the gap of knowledge on this particular matter.
- Conditions
- Gastroesophageal; Reflux With Esophagitis, Gastroesophageal Reflux, GERD, Heartburn, Non-erosive Reflux Disease, Esophagitis
- Being tested
- Dietary assessment
- Keywords
- food diversity, dietary pattern, healthy eating pattern, oesophagitis, GERD
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux, Heartburn, Non-Erosive Reflux Disease, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary assessmentProcedure or surgery
Also called Food frequency questionnaire
Dietary assessment is not within standards of care for patients with gastroesophageal reflux disease in Russia. Subjects enrolled to the study are to be interviewed on most common foods consumption in terms of frequency of use and sizes of portions.
| Study group | Role | What they receive |
|---|---|---|
| GERD | Experimental | Patients with verified gastroesophageal reflux disease Receives: Procedure: Dietary assessment |
| Contol | Other | Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination Receives: Procedure: Dietary assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
grains consumption diversity
Mean number of different types of grains consumed in form of different foods or food products a month during 12-months period
Measured: a month
meat consumption diversity
Mean number of different types of meat consumed in form of different foods or food products a month during 12-months period
Measured: a month
poultry consumption diversity
Mean number of different types of poultry consumed in form of different foods or food products a month during 12-months period
Measured: a month
fish consumption diversity
Mean number of different types of fish consumed in form of different foods or food products a month during 12-months period
Measured: a month
flour consumption diversity
Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period
Measured: a month
vegetables consumption diversity
Mean number of different types of vegetables consumed as is or in the form of different foods or food products
Measured: a month
Fruits consumption diversity
Mean number of different types of fruits consumed as is or in the form of different foods or food products
Measured: a month
Fats consumption diversity
Mean number of different types of fats consumed in the form of different foods or food products a month by 12 month period
Measured: a month
Secondary outcomes (1)
GERD-associated dietary pattern
complex of nutrients and/or foods (food products) which correlates with presence of GERD. The correlation coefficients for each food item is range in the order of significance and direction of the relationship and in accordance to the amount of the product consumed, than is formed to the integral mean.
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Jan 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal; Reflux With EsophagitisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Dietary assessment with the use of computer-based food frequency questionnaire will be performed to patients with established diagnosis of gastroesophageal reflux disease in comparison to the representatives of a control group (without the disease).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Russian Science Foundation
- Responsible party
- Principal investigator, Vasily Isakov, Russian Academy of Medical Sciences
- Investigators
- Vasily Isakov, MD, PhD, Professor, AGAF, Study chair, FRC nutrition and biotechnologySergey Morozov, MD, PhD, Principal investigator, FRC Nutrition and Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252144
- Sponsor's protocol ID
- 19-76-30014 GERD
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data may be shared by request after study completion, except subjects' personal (identification) information
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dietary Patterns and Food Diversity in Russian GERD Patients
- ClinicalTrials.gov ID
- NCT04252144
- Acronym / sponsor ID
- 19-76-30014 GERD
- Conditions
- Gastroesophageal; Reflux With Esophagitis, Gastroesophageal Reflux, GERD, Heartburn, Non-erosive Reflux Disease, Esophagitis
- Keywords
- food diversity, dietary pattern, healthy eating pattern, oesophagitis, GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Russian Science Foundation
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Feb 2020 (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.
The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients
Detailed description
The study of dietary patterns may provide complex vision of an association between consumption of specific foods, or groups of food products and manifestations of gastroesophageal reflux disease (symptoms: heartburn and acid regurgitation; endoscopic findings - oesophagitis). Only limited data on this matter are published to the moment and they predominantly concerns outcomes of gastroesophageal reflux disease (oesophageal adenocarcinoma or Barrett's oesophagus). Taking into the consideration that earlier studies found significant differences in consumption of nutrients in different world regions, new data on food patterns of dietary patterns in Russian GERD patients could partly fill in the gap of knowledge on this particular matter.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dietary assessment with the use of computer-based food frequency questionnaire will be performed to patients with established diagnosis of gastroesophageal reflux disease in comparison to the representatives of a control group (without the disease).
| Arm | Type | Receives |
|---|---|---|
| GERD | Experimental | Procedure: Dietary assessmentPatients with verified gastroesophageal reflux disease |
| Contol | Other | Procedure: Dietary assessmentMostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to participate (signed the informed consent form);
- willingness to follow all the required procedures;
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding females;
- Neoplasms, current or by the medical history (except local skin cancer successfully treated);
- History of chest or abdominal surgery, except appendectomy and cholecistectomy (in case when no consequences of these operations like adhesive disease of the abdominal cavity are present);
- Co-morbid conditions which can influence or mask the symptoms of GERD (including, but not limited to: ischaemic heart disease, severe pulmonary disease, severe depression or anxiety, etc);
- the use of concomitant medications that may influence on the symptoms or other manifestations of gastroesophageal reflux disease: NSAIDs, corticosteroids (except topic ones for no longer than 2 weeks), any medications directly influencing mood and function of central nervous system (antidepressants, anxiolytics, anti-anxiety agents, anticonvulsant etc) at the moment of enrolment and during a 2 half-life period of the certain drug;
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 |
|---|---|---|
| Dietary assessmentAlso: Food frequency questionnaireDietary assessment is not within standards of care for patients with gastroesophageal reflux disease in Russia. Subjects enrolled to the study are to be interviewed on most common foods consumption in terms of frequency of use and sizes of portions. | Procedure or surgery | Contol, GERD |
Primary outcome
grains consumption diversity
Time frame: a month
Mean number of different types of grains consumed in form of different foods or food products a month during 12-months period
meat consumption diversity
Time frame: a month
Mean number of different types of meat consumed in form of different foods or food products a month during 12-months period
poultry consumption diversity
Time frame: a month
Mean number of different types of poultry consumed in form of different foods or food products a month during 12-months period
fish consumption diversity
Time frame: a month
Mean number of different types of fish consumed in form of different foods or food products a month during 12-months period
flour consumption diversity
Time frame: a month
Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period
vegetables consumption diversity
Time frame: a month
Mean number of different types of vegetables consumed as is or in the form of different foods or food products
Fruits consumption diversity
Time frame: a month
Mean number of different types of fruits consumed as is or in the form of different foods or food products
Fats consumption diversity
Time frame: a month
Mean number of different types of fats consumed in the form of different foods or food products a month by 12 month period
1 secondary outcome
GERD-associated dietary pattern
Time frame: a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes. Study data may be shared by request after study completion, except subjects' personal (identification) information
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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.
Vasily Isakov, MD, PhD, Professor, AGAF study chair
FRC nutrition and biotechnology
Sergey Morozov, MD, PhD principal investigator
FRC Nutrition and Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary assessment in people with Gastroesophageal; Reflux With Esophagitis and Gastroesophageal Reflux, run by Russian Academy of Medical Sciences 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergey Morozov, MD, PhD (+79104681801, morosoffsv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grains consumption diversity (time frame: a month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2022.