Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Mucofalk
Intervention description: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Intervention MeSH terms: Psyllium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD; psyllium; Lower esophageal sphincter; Esophageal motility; Dietary fiber; Heartburn; gastroesophageal reflux; non-erosive gastroesophageal reflux disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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