Status:
COMPLETED
Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD
Lead Sponsor:
Russian Academy of Medical Sciences
Collaborating Sponsors:
Dr. Falk Pharma GmbH
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation. These are caused by...
Detailed Description
During the study 14-days screening period is provided to evaluate H.pylori and endoscopic status of the patient and to confirm the presence of dietary fiber deficiency (based on standard computerized ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of non-erosive form of Gastroesophageal Reflux disease
- Dietary fiber deficiency by dietary questionnaire
- pathological gastroesophageal reflux by 24-hours esophageal pH-impedance examination
- willingness to participate (signed informed consent)
Exclusion
- presence of esophageal mucosal damages (esophagitis) by endoscopic evaluation
- gastrointestinal surgery in anamnesis
- current pregnancy or breast-feeding
- known hypersensitivity to Mucofalk or its components
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01882088
Start Date
April 1 2012
End Date
December 1 2016
Last Update
August 13 2019
Active Locations (1)
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1
Research Institute of Nutrition of Russian Academy of Medical Sciences
Moscow, Russia, 115446