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
Study type: Interventional
Phase: Phase 4

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.
    

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 dietary questionnaire). On the baseline physical examination, GERD-Q
      questionnaire, GERD symptom severity scale (by Likert), Bristol stool scale, high resolution
      esophageal manometry and 24-hours esophageal pH-impedance studies are to be provided. Since
      baseline, up to day 10 Mucofalk 15 g/day in three times a day (TID) regimen is to be given.
      All the patient will receive standardized menu. Repeat evaluation of symptoms, high
      resolution esophageal manometry and 24-hours esophageal pH-impedance are to be done at the
      day 10 of the study.
    

Intervention name(s): Mucofalk
Intervention type(s): Drug
Intervention description(s): Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Other intervention name(s): Psyllium
Intervention MeSH terms: Psyllium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; psyllium; Lower esophageal sphincter; Esophageal motility; Dietary fiber; Heartburn; gastroesophageal reflux; non-erosive gastroesophageal reflux disease