Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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 increasing number of transient lower esophageal sphincter relaxations,
regularly recurring reflux of gastric content into oesophagus, acidification of the esophagus
and consequent esophageal mucosa damage. In addition, an important role is played by the
increase in production of hydrochloric acid in the stomach, the slowdown in the evacuation of
the contents from the stomach and increase of gastric and intra-abdominal pressure. All of
these factors may depend on the patient's diet.
Theoretical premises of the positive influence of including dietary fiber on the course of
gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide
(NO) containing in food, which in turn has relaxing effects on the lower esophageal
sphincter. In addition, fiber deficiency has been shown to be associated with increased
chance of developing hiatal hernia, which is associated with greater risk of the disease
manifestations. There is lack of data to confirm that dietary interventions like higher
dietary fiber intake may lead to lower frequency of GERD symptoms and influence objective
criteria (those, obtained during esophageal pH-impedance (here and further: pH - pondus
hydrogenii, i.e. quantity of hydrogen, a scale to measure acidity of a solution) recording
and high resolution esophageal manometry).
Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata
(ispaghula, psyllium). High content of mucuses in the composition of psyllium seed allows it
to include to group of soft food fibers, which has fundamental value for the appointment of a
drug at a number of diseases, when, for example, the use of coarse food fibres not
recommended or contraindicated.
Mucofalk is the registered medicinal (registration number of the Russian State register of
medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma Gesellschaft
mit beschränkter Haftung (GmbH), packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage
and administration: orally, adults and children over 12 years - 1 pack. 2-6 times a day.
Before use, the contents of 1 packet poured in a glass, in which slowly poured with cold
water (150 ml), stir and drink immediately. Then drink another glass of liquid.