Investigating the impact of diet on gastroesophageal reflux disease symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Study coordinator: Sergey Morozov, MD, PhD
• Email: morosoffsv@mail.ru
• Phone: +74996131091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD

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• Predictors of symptom improvement after laparoscopic fundoplication

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• Managing GERD with personalized dietary changes and guided education

  A dietary plan and written education are being tested to see if they help adults with chronic GERD reduce symptoms.

  Recruiting Hualien Tzu Chi General Hospital · Hualien City, Taiwan · NCT07754721

• GERD patient registry study using a large prospective clinical database

  A large group of adults with gastroesophageal reflux disease are being looked at in real-world care to see who they are, what treatments they get, and how symptoms and well-being change after treatment.

  Recruiting Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT07749989

• Quality sleep improvement with evening topical therapy for nocturnal GERD

  This trial tests a medical device given before bed to see if it reduces nighttime GERD symptoms and improves sleep and quality of life in adults with nocturnal reflux.

  Recruiting Cellmedis · Warsaw, Masovian Voivodeship and 1 other locations · NCT07700342

• Mindfulness Intervention for Emotional Distress in GERD

  This online mindfulness program is being tested to see if it can help adults with GERD feel less emotional distress and experience fewer reflux symptoms.

  Recruiting at 13 sites Peking University · Beijing, Beijing Municipality and 14 other locations · NCT07667894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.