An interventional study of Dietary assessment in Gastroesophageal; Reflux With Esophagitis, Gastroesophageal Reflux and GERD, sponsored by Russian Academy of Medical Sciences. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Russian Academy of Medical Sciences · Not applicable, Interventional, and Prevention
The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients
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.
83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.
This study's planned enrollment of 150 is above the median of 135 across 60 interventional studies indexed under Esophagitis, Peptic.
Browse Esophagitis, Peptic studies →Russian Academy of Medical Sciences is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with verified gastroesophageal reflux disease
Procedure: Dietary assessment
Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination
Procedure: Dietary assessment
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.
Also known as: Food frequency questionnaire
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: a month
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.
Time frame: a year
Plan to share: Yes — Study data may be shared by request after study completion, except subjects' personal (identification) information
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: After the study completion, available for 2 years
Access criteria: By request
Data sharing details ↗ · ion.ru
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Sep 2023, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Russian Academy of Medical Sciences