NL-OMON52836
Recruiting
Phase 2
Sleep positional therapy for the treatment of nocturnal gastroesophageal reflux - LEFT
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- gastroesophageal reflux disease
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent.
- •Age above 18 years.
- •Symptoms of heartburn and/or acid regurgitation at least 2 times a week
- •during the night.
- •A total reflux symptom score \>\=8 (measured through the GERDQ questionnaire
- •Minimal of 1\.5% esophageal acid exposure during the night.
Exclusion Criteria
- •Surgery of the GI tract other than appendectomy or cholecystectomy.
- •Use of any medication with a potential effect on gastrointestinal motility,
- •secretion or sensitivity that cannot be stopped for the duration of the study
- •(e.g. H2\-blockers, antidepressants, prokinetics, antacids).
- •History of gastrointestinal cancer.
- •Known diabetes.
- •Regular use of sleep medication (benzodiazepines) that cannot be stopped.
- •Severe and clinically unstable concomitant disease (e.g. liver,
- •cardiovascular or lung disease, neurological or psychiatric disorders, cancer
- •or AIDS and other endocrine disorders).
Outcomes
Primary Outcomes
Not specified
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