Clinical trial NCT01882088: Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD
Official title: Phase IV Non Comparative Study of the Impact of Dietary Fiber Deficiency Correction Using Mucofalk® on Clinical Features and Motor Function of the Esophagus in Patients With Non-erosive Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
psyllium
Lower esophageal sphincter
Esophageal motility
Dietary fiber
Heartburn
gastroesophageal reflux
non-erosive gastroesophageal reflux disease
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Dr. Falk Pharma GmbH
First posted: 2013-06-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Number of Gastroesophageal Refluxes
timeFrame: End of Treatment, on day 10 of psyllium intake
Secondary outcomes:
measure: Acid Exposure Time
timeFrame: End of Treatment, on day 10 of psyllium intake
measure: Number of Acid Gastroesophageal Refluxes
timeFrame: End of Treatment, on day 10 of psyllium intake
measure: Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake
timeFrame: 7 days prior to EOT
measure: Minimal Lower Esophageal Sphincter Pressure at Rest
timeFrame: End of Treatment, on day 10 of psyllium intake
measure: Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the Day 10 of Psyllium Intake)
timeFrame: End of Treatment, on day 10 of psyllium intake
measure: Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows
timeFrame: End of Treatment, on day 10 of psyllium intake
measure: Residual Lower Esophageal Sphincter Pressure
timeFrame: End of Treatment, on day 10 of psyllium intake
Other outcomes:
measure: Mean Lower Esophageal Sphincter Pressure (at Rest)
timeFrame: End of Treatment, on day 10 of psyllium intake
measure: Stools Per Week
timeFrame: 7 days
Locations:
city: Moscow
country: Russian Federation
facility: Research Institute of Nutrition of Russian Academy of Medical Sciences
Study officials:
affiliation: Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology
name: Vasily A Isakov, MD,PhD,AGAF
role: STUDY_CHAIR
affiliation: Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology
name: Sergey Morozov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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