Gastroesophageal reflux symptoms among Italian university students: epidemiology and dietary correlates using automatically recorded transactions.
Irene Martinucci, Michela Natilli, Valentina Lorenzoni...
https://pubmed.ncbi.nlm.nih.gov/30016938/Actively Recruiting
Led by Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Updated on 2025-08-03
150
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating how long-term adherence to diet affects symptoms and disease progression in people with gastroesophageal reflux disease GERD. This study includes patients with different forms of GERD, such as non-erosive GERD, reflux-oesophagitis, and hypersensitive oesophagus, all diagnosed using modern techniques like questionnaires, endoscopy, and pH-impedance recordings. The study aims to understand the impact of diet alongside other factors such as body weight, physical activity, smoking, and medications. Participants will be observed over three years, with diet assessed using a computer-based food frequency questionnaire every three months. The study groups are formed based on changes in disease manifestations, including symptom severity and oesophagitis grade, as well as adherence to diet, physical activity changes, and use of anti-secretory medications. Data analysis will compare these factors to initial assessments to evaluate their influence on disease progression. Throughout the study, participants will undergo standard examinations and complete questionnaires to assess symptoms like heartburn frequency and severity. The primary outcomes measured include weekly heartburn frequency, daily heartburn severity, and the grade of erosive oesophagitis at two years after enrollment. Researchers will monitor participants adherence to diet and medications, physical activity, and other health factors to understand their effects on GERD over time. The study is expected to continue until the end of 2027.
CONDITIONS
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
S
Sergey Morozov, MD, PhD
V
Vasily Kropochev, MD
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Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants have their diet adherence, physical activity changes, and use of antisecretory agents assessed over time to observe changes in gastroesophageal reflux disease manifestations.
Visits every 3 months for diet assessment and other evaluations
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/16928254/Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Lead Sponsor