Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD (OGIG-130-1)
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|ClinicalTrials.gov Identifier: NCT01882088|
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : August 1, 2019
Last Update Posted : August 13, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Other Name: Psyllium
- 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
- 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
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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
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
|Research Institute of Nutrition of Russian Academy of Medical Sciences|
|Moscow, Russian Federation, 115446|
|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|