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| ID | Type | Description | Link |
|---|---|---|---|
| RussianAMS-1 | Other Identifier | RussianAMS |
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| Name | Class |
|---|---|
| Dr. Falk Pharma GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucofalk | Experimental | Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucofalk | Drug | Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gastroesophageal Refluxes | 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 | End of Treatment, on day 10 of psyllium intake |
| Measure | Description | Time Frame |
|---|---|---|
| Acid Exposure Time | 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 | End of Treatment, on day 10 of psyllium intake |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Lower Esophageal Sphincter Pressure (at Rest) | This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 10 of psyllium intake. | End of Treatment, on day 10 of psyllium intake |
| Stools Per Week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vasily A Isakov, MD,PhD,AGAF | Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology | Study Chair |
| Sergey Morozov, MD, PhD | Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Nutrition of Russian Academy of Medical Sciences | Moscow | 115446 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16817916 | Background | Ronkainen J, Aro P, Storskrubb T, Lind T, Bolling-Sternevald E, Junghard O, Talley NJ, Agreus L. Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population--the Kalixanda study. Aliment Pharmacol Ther. 2006 Jun 15;23(12):1725-33. doi: 10.1111/j.1365-2036.2006.02952.x. | |
| 11159879 | Background |
| Label | URL |
|---|---|
| Dr. Falk Pharma Gmbh | View source |
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Study protocol, results of the study could be shared
within 2 years after study completion
Official regulatory institutions request, official request by researchers or researchers organizations
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36 patients were enrolled. 1 patient withdrew informed consent before day 0, 1 excluded due to non-compliance, 1 could not tolerate oesophageal manometry, in 1 case there was no possibility to perform the manometry. Migration of the pH-impedance probe was found in two patients. The data of these mentioned 6 patients were excluded from the analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | Mucofalk | Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The shown data are from those patients who successfully completed the study and whose complete data were available for the final analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Mucofalk | Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Gastroesophageal Refluxes | 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 | Thirty-six patients were enrolled, complete data from 30 were included in the final analysis. | Posted | Mean | Standard Deviation | refluxes | End of Treatment, on day 10 of psyllium intake |
|
Mandatory individual (each subject) time point for the assessment of adverse events presence was the Day10 of psyllium intake (end of treatment). Each participant was asked to contact study team immediately in case of any adverse event and was provided with primary and backup telephone contacts including those to use outside the working hours.
Standard definitions were used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mucofalk | Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal |
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Absence of placebo control. Due to the nature of psyllium and its preparation, it is almost impossible to produce a comparator of similar viscosity, solubility in water, and taste. Relatively small group of patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sergey Morozov, Senior Reseracher, Dpt Gastroenterology and Hepatology | Federal research Center of Nutrition and Biotechnology | +74996131091 | morosoffsv@mail.ru |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Number of Acid Gastroesophageal Refluxes | 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. | End of Treatment, on day 10 of psyllium intake |
| Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake | 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 | 7 days prior to EOT |
| Minimal Lower Esophageal Sphincter Pressure at Rest | 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. | End of Treatment, on day 10 of psyllium intake |
| Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the 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. | End of Treatment, on day 10 of psyllium intake |
| Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows | 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 | End of Treatment, on day 10 of psyllium intake |
| Residual Lower Esophageal Sphincter Pressure | These data are obtained during high resolution esophageal manometry studies. The end of treatment characteristics were compared to the baseline ones. | End of Treatment, on day 10 of psyllium intake |
Episodes of stools were calculated during 7-day period. Mean number at the end point was compared to the baseline one
| 7 days |
| Terry P, Lagergren J, Ye W, Wolk A, Nyren O. Inverse association between intake of cereal fiber and risk of gastric cardia cancer. Gastroenterology. 2001 Feb;120(2):387-91. doi: 10.1053/gast.2001.21171. |
| 4124047 | Background | Burkitt DP, James PA. Low-residue diets and hiatus hernia. Lancet. 1973 Jul 21;2(7821):128-30. doi: 10.1016/s0140-6736(73)93067-5. No abstract available. |
| 15542505 | Background | Nilsson M, Johnsen R, Ye W, Hveem K, Lagergren J. Lifestyle related risk factors in the aetiology of gastro-oesophageal reflux. Gut. 2004 Dec;53(12):1730-5. doi: 10.1136/gut.2004.043265. |
| 15591498 | Background | El-Serag HB, Satia JA, Rabeneck L. Dietary intake and the risk of gastro-oesophageal reflux disease: a cross sectional study in volunteers. Gut. 2005 Jan;54(1):11-7. doi: 10.1136/gut.2004.040337. |
| 16782525 | Background | Karamanolis G, Tack J. Nutrition and motility disorders. Best Pract Res Clin Gastroenterol. 2006;20(3):485-505. doi: 10.1016/j.bpg.2006.01.005. |
| inadequate pH-impedance tracings |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body mass index, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| weight, kg | Mean | Standard Deviation | kg |
|
| smoking status (yes) | Number of participants who answered "yes" to the question about smoking status | Count of Participants | Participants |
|
| alcohol intake (yes) | Number of the participants who drank alcohol | Count of Participants | Participants |
|
| alcohol use (g/day) | Mean | Standard Deviation | g/day |
|
| basal dietary fiber intake, g/day | Mean | Standard Deviation | g/day |
|
| hiatal hernia presence | Count of Participants | Participants |
|
| hiatal hernia size | out of those who had hiatal hernia | Mean | Standard Deviation | cm |
|
| stools per week, n | number of stools per week | Mean | Standard Deviation | stools per week |
|
| Number of Gastroesophageal Refluxes | Number of gastroesophageal refluxes registered with 24-hours esophageal pH-impedance tracing | Mean | Standard Deviation | refluxes a day |
|
| Acid exposure time | Percent of time when pH values at 5 cm above upper border of the lower esophageal sphincter were less than 4, on 24-hours oesophageal pH-impedance study. Acid exposure time (AET) is a commonly accepted term | Mean | Standard Deviation | Percent of time pH<4 per 24-hours period |
|
| Number of acid gastroesophageal refluxes | Number of acid refluxes is 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. | Mean | Standard Deviation | acid refluxes per day |
|
| Number of patients experiencing heartburn during 7 days prior to baseline | Presence of heartburn during 7 days prior to baseline was assessed with the use of a standardized questionnaire. This data was then compared to the data obtained at point EOT | Count of Participants | Participants |
|
| minimal lower esophageal sphincter pressure at rest, mm Hg | Obtained during high resolution oesophageal manometry study at the baseline | Mean | Standard Deviation | mm Hg |
|
| Mean resting lower esophageal sphincter (LES) pressure after 10 water swallows | The data are obtained during high resolution oesophageal manometry study, this outcome is measured after 10 water swallows by 5 ml each. In this section baseline characteristics are shown | Mean | Standard Deviation | mm Hg |
|
| Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows | The results were obtained with the use of high resolution oesophageal manometry. This parameter is based on measurements of the pressure during 10 water swallows by 5 ml water each. Normally it takes 10-20 minutes to perform this test. Here baseline characteristics are shown | Mean | Standard Deviation | mm Hg |
|
| Residual Lower Esophageal Sphincter Pressure | These data are obtained with the use of high resolution oesophageal manometry on the day before treatment was initiated | Mean | Standard Deviation | mm Hg |
|
| Mean Lower Esophageal Sphincter Pressure (at Rest) | This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 1 of psyllium intake | Mean | Standard Deviation | mm Hg |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Acid Exposure Time | 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 | Thirty-six patients were enrolled, complete data from 30 were included in the final analysis. | Posted | Mean | Standard Deviation | Percent of time pH<4 per 24-hours period | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Secondary | Number of Acid Gastroesophageal Refluxes | 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. | 36 subjects were enrolled, data of 30 of them were included to the final analysis | Posted | Mean | Standard Deviation | acid refluxes | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Secondary | Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake | 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 | 36 patients were enrolled, data of 30 of them were included to the final analysis | Posted | Number | Number of participants | 7 days prior to EOT |
|
|
|
|
| Secondary | Minimal Lower Esophageal Sphincter Pressure at Rest | 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. | 36 patients were enrolled. data of the 30 of them were available for the final analysis | Posted | Mean | Standard Deviation | mm Hg | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Secondary | Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the 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. | 36 patients enrolled, data of the 30 of them were available for the final analysis | Posted | Mean | Standard Deviation | mm Hg | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Secondary | Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows | 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 | 36 patients were enrolled, data of 30 of them were available for the final analysis | Posted | Mean | Standard Deviation | mm Hg | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Secondary | Residual Lower Esophageal Sphincter Pressure | These data are obtained during high resolution esophageal manometry studies. The end of treatment characteristics were compared to the baseline ones. | 36 non-erosive reflux disease (NERD) patients were enrolled, the data of 30 of them were available for the final analysis | Posted | Mean | Standard Deviation | mm Hg | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Other Pre-specified | Mean Lower Esophageal Sphincter Pressure (at Rest) | This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 10 of psyllium intake. | 36 subjects were enrolled, data of 30 of them were available for the final analysis | Posted | Mean | Standard Deviation | mm Hg | End of Treatment, on day 10 of psyllium intake |
|
|
|
|
| Other Pre-specified | Stools Per Week | Episodes of stools were calculated during 7-day period. Mean number at the end point was compared to the baseline one | 36 patients were enrolled, complete data of 30 of them were available for the final analysis | Posted | Mean | Standard Deviation | stools per week | 7 days |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |