Gastroesophageal Reflux DiseasePhase 4OGIG-130-1NCT01882088
Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD
A Phase 4 study testing Mucofalk in people with Gastroesophageal Reflux Disease, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Mucofalk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- Apr 2012to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research Institute of Nutrition of Russian Academy of Medical Sciences
Moscow, 115446
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Mucofalk
- Keywords
- GERD, psyllium, Lower esophageal sphincter, Esophageal motility, Dietary fiber, Heartburn, gastroesophageal reflux, non-erosive gastroesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucofalkDrug
Also called Psyllium
Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
| Study group | Role | What they receive |
|---|---|---|
| Mucofalk | Experimental | Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Receives: Drug: Mucofalk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of Treatment, on day 10 of psyllium intake
Secondary outcomes (7)
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
Measured: End of Treatment, on day 10 of psyllium intake
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: End of Treatment, on day 10 of psyllium intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Responsible party
- Principal investigator, Vasily Isakov, Russian Academy of Medical Sciences
- Investigators
- Vasily A Isakov, MD,PhD,AGAF, Study chair, Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&HepatologySergey Morozov, MD, PhD, Principal investigator, Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882088
- Sponsor's protocol ID
- ION RAMS
- Other IDs
- RussianAMS-1
- Acronym
- OGIG-130-1
- Status last verified
- Jul 2019
- First submitted
- 16 Jun 2013
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Study protocol, results of the study could be shared
Publications
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.
PubMed 16817916Terry 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.
PubMed 11159879Burkitt 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.
PubMed 4124047Nilsson 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.
PubMed 15542505El-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.
PubMed 15591498Karamanolis 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.
PubMed 16782525
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01882088
- Acronym / sponsor ID
- OGIG-130-1 / ION RAMS
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, psyllium, Lower esophageal sphincter, Esophageal motility, Dietary fiber, Heartburn, gastroesophageal reflux, non-erosive gastroesophageal reflux disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucofalk | Experimental | Drug: MucofalkMucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MucofalkAlso: PsylliumMucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal | Drug | Mucofalk |
Primary outcome
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
7 secondary outcomes
Acid Exposure Time
Time frame: End of Treatment, on day 10 of psyllium intake
Number of Acid Gastroesophageal Refluxes
Time frame: End of Treatment, on day 10 of psyllium intake
Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake
Time frame: 7 days prior to EOT
Minimal Lower Esophageal Sphincter Pressure at Rest
Time frame: 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)
Time frame: End of Treatment, on day 10 of psyllium intake
Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows
Time frame: End of Treatment, on day 10 of psyllium intake
Residual Lower Esophageal Sphincter Pressure
Time frame: End of Treatment, on day 10 of psyllium intake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16817916Ronkainen 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.
- Background: PubMed 11159879Terry 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.
- Background: PubMed 4124047Burkitt 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.
- Background: PubMed 15542505Nilsson 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.
- Background: PubMed 15591498El-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.
- Background: PubMed 16782525Karamanolis 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.
- Dr. Falk Pharma GmbhLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol, results of the study could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasily A Isakov, MD,PhD,AGAF study chair
Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology
Sergey Morozov, MD, PhD principal investigator
Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mucofalk in people with Gastroesophageal Reflux Disease, run by Russian Academy of Medical Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Gastroesophageal Refluxes (time frame: End of Treatment, on day 10 of psyllium intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01882088, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.