Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD (OGIG-130-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882088
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : August 1, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Dr. Falk Pharma GmbH
Information provided by (Responsible Party):
Vasily Isakov, Russian Academy of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Mucofalk Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber GERD

Arm Intervention/treatment
Experimental: Mucofalk
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Drug: Mucofalk
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Other Name: Psyllium




Primary Outcome Measures :
  1. Number of Gastroesophageal Refluxes [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    Number of gastroesophageal refluxes registered with 24-hours esophageal pH-impedance on the 10th day of psyllium intake. Statistical data represent the results of the comparison of the data obtained on the day 10 of study (EOT) with the baseline characteristics provided in the specific section


Secondary Outcome Measures :
  1. Acid Exposure Time [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    Percent of time with pH less than 4 at 5 cm above upper border of lower oesophageal sphincter per 24-hours oesophageal pH-impedance recording on the day 10 of psyllium intake. This outcome measure was compared to the baseline characteristics provided in the specific section of the study description

  2. Number of Acid Gastroesophageal Refluxes [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    Number of acid refluxes was measured by 24-hours oesophageal pH-impedance recordings. Reflux was considered as acid when oesophageal pH was less than 4 and the impedance revealed backward flow of the stomach content into the oesophagus. Outcome measure reflects the data of day 10 of psyllium intake. Statistics reflects comparison between EOT and baseline data.

  3. Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake [ Time Frame: 7 days prior to EOT ]
    Presence of heartburn during 7 days prior to the day 10 of psyllium intake was evaluated with a standardized questionnaire. This result was assessed at EOT

  4. Minimal Lower Esophageal Sphincter Pressure at Rest [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    Obtained during esophageal high resolution manometry study. End of treatment data were compared to the baseline. Per standard, resting pressure is measured during 30 seconds. High resolution manometry data on day 10 was compared to baseline.

  5. Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the Day 10 of Psyllium Intake) [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    The data are obtained during high resolution esophageal manometry study on the day 10 of psyllium intake. This outcome is measured after 10 water swallows by 5 ml each. The study usually lasts for about 15 to 20 minutes. Data of high-resolution esophageal manometry examination at baseline and on the day 10 of psyllium intake were compared.

  6. Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    The results obtained during high resolution esophageal manometry studies. This parameter is obtained after 10 water swallows by 5 ml each. Data of high resolution esophageal manometry (examination usually lasts for 10-20 min) on the day 10 of psyllium intake were compared to the baseline characteristics. The data were compared to baseline characteristics

  7. Residual Lower Esophageal Sphincter Pressure [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    These data are obtained during high resolution esophageal manometry studies. The end of treatment characteristics were compared to the baseline ones.


Other Outcome Measures:
  1. Mean Lower Esophageal Sphincter Pressure (at Rest) [ Time Frame: End of Treatment, on day 10 of psyllium intake ]
    This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 10 of psyllium intake.

  2. Stools Per Week [ Time Frame: 7 days ]
    Episodes of stools were calculated during 7-day period. Mean number at the end point was compared to the baseline one



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882088


Locations
Layout table for location information
Russian Federation
Research Institute of Nutrition of Russian Academy of Medical Sciences
Moscow, Russian Federation, 115446
Sponsors and Collaborators
Russian Academy of Medical Sciences
Dr. Falk Pharma GmbH
Investigators
Layout table for investigator information
Study Chair: Vasily A Isakov, MD,PhD,AGAF Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology
Principal Investigator: Sergey Morozov, MD, PhD Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Vasily Isakov, MD, PhD, AGAF, Professor, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01882088     History of Changes
Other Study ID Numbers: ION RAMS
RussianAMS-1 ( Other Identifier: RussianAMS )
First Posted: June 20, 2013    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 13, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol, results of the study could be shared
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: within 2 years after study completion
Access Criteria: Official regulatory institutions request, official request by researchers or researchers organizations
URL: http://ion.ru
Keywords provided by Vasily Isakov, Russian Academy of Medical Sciences:
GERD
psyllium
Lower esophageal sphincter
Esophageal motility
Dietary fiber
Heartburn
gastroesophageal reflux
non-erosive gastroesophageal reflux disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Psyllium
Cathartics
Gastrointestinal Agents