Overview

This trial is active, not recruiting.

Condition gastroesophageal reflux disease
Treatment mucofalk
Phase phase 4
Sponsor Russian Academy of Medical Sciences
Collaborator Dr. Falk Pharma GmbH
Start date April 2012
End date September 2016
Trial size 30 participants
Trial identifier NCT01882088, ION RAMS, RussianAMS-1

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 about diet modification with its enreaching by dietary fibers and their type on the symptoms frequency and objective (i.e. esophageal pH-impedance and manometric) parameters.

Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata (isphagula, 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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
mucofalk Psyllium
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal

Primary Outcomes

Measure
change in number of refluxes
time frame: a day

Secondary Outcomes

Measure
change in duration of gastroesophageal refluxes
time frame: a day
change in a number of acid gastroesophageal refluxes
time frame: a day
change in number of heartburn episodes
time frame: a day

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Clinical diagnosis of non-erosive form of Gastroesophageal Reflux disease - Dietary fiber deficiency by dietary questionnaire - pathological gastroesophageal reflux by 24-hours esopageal pH-impedansometry - 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

Additional Information

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
Principal investigator Sergey Morozov, MD, PhD
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 TID regimen is to be given. All the patient will receive standardized menu. Repeat evaluation of symptoms, high resolution esophageal manometry and 24-hours esophagel pH-impedance are to be done at the day 10 of the study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Russian Academy of Medical Sciences.