Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04255693

Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence

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

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to participate based on signed informed consent
  • Diagnosis of gastroesophageal reflux disease with typical symptoms like heartburn or regurgitation at least weekly for 3 months and symptom history of at least 6 months
  • Previous response to proton pump inhibitors
  • Pathological gastroesophageal reflux confirmed by 24-hour oesophageal pH-impedance monitoring according to Lyon consensus definitions
  • Age between 18 and 80 years
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding females
  • Abdominal or chest surgery except appendectomy or cholecystectomy without adhesive disease
  • Constant use of non-steroidal anti-inflammatory agents (NSAIDs); sporadic use allowed if discontinued at least 2 weeks before enrollment
  • History or current evidence of cancer except successfully treated skin cancer in situ
  • Severe conditions risking data misinterpretation or participant safety including advanced heart failure, uncontrolled hypertension, severe neurological disorders, decompensated liver cirrhosis, severe psychological disorders
  • Participant may withdraw consent at any time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Trial Site Locations

Total: 1 location

1

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

Moscow, Russia, 115446

Actively Recruiting

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Research Team

S

Sergey Morozov, MD, PhD

V

Vasily Kropochev, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus.

Nimish Vakil, Sander V van Zanten, Peter Kahrilas...

https://pubmed.ncbi.nlm.nih.gov/16928254

Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group.

S Roman, C P Gyawali, E Savarino...

https://pubmed.ncbi.nlm.nih.gov/28370768

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