Investigating the impact of diet on gastroesophageal reflux disease symptoms
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
This study is testing how sticking to certain diets for a long time can affect symptoms in people with gastroesophageal reflux disease (GERD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04255693 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how long-term adherence to specific dietary habits affects the manifestations of gastroesophageal reflux disease (GERD). It will involve a cohort of patients diagnosed with various forms of GERD, including non-erosive GERD and erosive esophagitis, confirmed through modern diagnostic techniques. Participants will undergo dietary assessments using a computer-based food frequency questionnaire at enrollment and every three months for three years. The study seeks to analyze the relationship between diet, behavior, and GERD outcomes over time.
Who should consider this trial
Good fit: Ideal candidates include individuals experiencing typical GERD symptoms at least weekly for three months and who have previously responded to proton pump inhibitors.
Not a fit: Patients who are pregnant, breastfeeding, or have undergone significant abdominal or chest surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary modifications that may alleviate GERD symptoms and improve patient quality of life.
How similar studies have performed: While some studies have explored the role of diet in GERD, this study's focus on long-term real-life effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * willingness to participate (based on the signed informed consent form); * presence of gastroesophageal reflux disease, based on the following: a) typical symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should be present at least weekly, be actual for at least 3 months prior to the enrolment, and the patient should report the history of symptoms which lasts for at least 6 months); b) previous response to the intake of proton pump inhibitors; c) data of 24-hours oesophageal pH-impedance monitoring with detected pathological gastroesophageal reflux according to the Lyon consensus definitions; Exclusion Criteria: * pregnant or breast-feeding females; * abdominal or chest surgery (except appendectomy or cholecystectomy in case they are not followed by adhesive disease of the abdominal organs); * constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of NSAIDs will be allowed in case the course of treatment was discontinued at least 2 weeks prior to the enrolment, in case that constant use of NSAIDs happen to be necessary after the enrolment, the patients may continue in the study but doses, frequency and duration of treatment should be carefully documented; * history or current evidence of cancer of any aetiology and location besides skin cancer in situ successfully treated before the enrolment; * severe patient's conditions which may lead to misinterpretation of data, or in case of patient's enrolment may put him at risk of exacerbation of co-morbid conditions, or in cases when on discretion of the investigator patient's condition would not allow him to complete the course of the observation. These conditions include, but not limited to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe depression or other psychological disorders; * the patient may stop his participation in the study at any time by informing the site personal about his/her decision to withdraw the consent.
Where this trial is running
Moscow
- Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Sergey Morozov, MD, PhD — Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
- Study coordinator: Sergey Morozov, MD, PhD
- Email: morosoffsv@mail.ru
- Phone: +74996131091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.