Gastroesophageal Reflux Disease (GERD)NCT02699060
Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD
A study testing Upper gastrointestinal endoscopy with biopsy and collection of refluxate and Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring in people with Gastroesophageal Reflux Disease (GERD), run by Ivashkin Vladimir Trofimovich at 2 sites in Russia.
Trial summary
This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Upper gastrointestinal endoscopy with biopsy and collection of refluxate and Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesRussia
- Study dates
- Feb 2016to Jan 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical (patients) part
- Signed informed consent
- Gender: Male or Female
- Age: 18-65 years of age
- 3. Clinically and/or endoscopically confirmed diagnosis of GERD
Who cannot join
- Clinical: (patient)
- Current treatment with proton pump inhibitors and/or histamine-2 receptor antagonists. These treatments should have been stopped at least 1 week prior to study inclusion.
- Female patients who are pregnant, planning to become pregnant or lactating
- Any acute diseases or conditions, exacerbations of concomitant chronic diseases (including but not limited to inflammatory bowel disease (IBD), ulcer disease etc.) at study start/inclusion and/or which are not resolved 14 days prior to study-enrolment.
- Participation in a clinical trial in the past 3 months
- Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
I.M.Sechenov First Moscow State Medical University
Moscow, 119991
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
Moscow, 127473
About this study
Official title: Experimental Study to Determine the Effects of Human Refluxate (Biliary, Gastric, Duodenogastric) on Macrophage Phenotype and Its Correlation With Different Forms of GERD: Motility Talent Group Study
This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.
Read the detailed description
Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80, CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega Ambulatory Impedance pH Recorder (Medical Measurements Systems).
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Upper gastrointestinal endoscopy with biopsy and collection of refluxate, Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
- Keywords
- GERD, Barrett's esophagus, macrophage, FSSG questionnaire
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper gastrointestinal endoscopy with biopsy and collection of refluxateProcedure or surgery
Also called EGD (esophagogastroduodenoscopy) with esophagus biopsy
we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa.
Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringProcedure or surgery
Also called HRM and 24-h esophageal pH monitoring
we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| NERD patients | Experimental | Patients have typical reflux syndrome without esophageal injury. Receives: Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate; Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring |
| EE patients | Experimental | Patients have erosion(s) or ulcer(s) in esophagus. Receives: Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate; Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring |
| BE patients | Experimental | Patients have esophageal specialized intestinal metaplasia. Receives: Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate; Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Reflux in GERD Patients
We analyzed the number of acid and weakly acid reflux episodes in GERD patients
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2019
- Study completionJan 2019
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 (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivashkin Vladimir Trofimovich
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Ivashkin Vladimir Trofimovich, I.M. Sechenov First Moscow State Medical University
- Investigators
- Vladimir Ivashkin, MD,PhD,Prof., Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699060
- Sponsor's protocol ID
- EPIDKO19
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2016
- Last updated
- 18 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhong YQ, Lin Y, Xu Z. Expression of IFN-gamma and IL-4 in the esophageal mucosa of patients with reflux esophagitis and Barrett's esophagus and their relationship with endoscopic and histologic grading. Dig Dis Sci. 2011 Oct;56(10):2865-70. doi: 10.1007/s10620-011-1696-9. Epub 2011 Apr 9.
PubMed 21479676Kohata Y, Fujiwara Y, Machida H, Okazaki H, Yamagami H, Tanigawa T, Watanabe K, Watanabe T, Tominaga K, Wei M, Wanibuchi H, Arakawa T. Role of Th-2 cytokines in the development of Barrett's esophagus in rats. J Gastroenterol. 2011 Jul;46(7):883-93. doi: 10.1007/s00535-011-0405-y. Epub 2011 May 18.
PubMed 21590343Gough MD, Ackroyd R, Majeed AW, Bird NC. Prediction of malignant potential in reflux disease: are cytokine polymorphisms important? Am J Gastroenterol. 2005 May;100(5):1012-8. doi: 10.1111/j.1572-0241.2005.40904.x.
PubMed 15842572Fitzgerald RC, Onwuegbusi BA, Bajaj-Elliott M, Saeed IT, Burnham WR, Farthing MJ. Diversity in the oesophageal phenotypic response to gastro-oesophageal reflux: immunological determinants. Gut. 2002 Apr;50(4):451-9. doi: 10.1136/gut.50.4.451.
PubMed 11889061
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study to Determine the Effects of Human Refluxate (Biliary, Gastric, Duodenogastric) on Macrophage Phenotype and Its Correlation With Different Forms of GERD: Motility Talent Group Study
- ClinicalTrials.gov ID
- NCT02699060
- Acronym / sponsor ID
- EPIDKO19
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, Barrett's esophagus, macrophage, FSSG questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ivashkin Vladimir TrofimovichUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Feb 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.
Detailed description
Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80, CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega Ambulatory Impedance pH Recorder (Medical Measurements Systems).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NERD patients | Experimental | Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate, Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringPatients have typical reflux syndrome without esophageal injury. |
| EE patients | Experimental | Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate, Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringPatients have erosion(s) or ulcer(s) in esophagus. |
| BE patients | Experimental | Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate, Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringPatients have esophageal specialized intestinal metaplasia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical (patients) part
- Signed informed consent
- Gender: Male or Female
- Age: 18-65 years of age
- 3. Clinically and/or endoscopically confirmed diagnosis of GERD
Key exclusion criteria (6 listed)
- Clinical: (patient)
- Current treatment with proton pump inhibitors and/or histamine-2 receptor antagonists. These treatments should have been stopped at least 1 week prior to study inclusion.
- Female patients who are pregnant, planning to become pregnant or lactating
- Any acute diseases or conditions, exacerbations of concomitant chronic diseases (including but not limited to inflammatory bowel disease (IBD), ulcer disease etc.) at study start/inclusion and/or which are not resolved 14 days prior to study-enrolment.
- Participation in a clinical trial in the past 3 months
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 |
|---|---|---|
| Upper gastrointestinal endoscopy with biopsy and collection of refluxateAlso: EGD (esophagogastroduodenoscopy) with esophagus biopsywe analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa. | Procedure or surgery | BE patients, EE patients, NERD patients |
| Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringAlso: HRM and 24-h esophageal pH monitoringwe analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours. | Procedure or surgery | BE patients, EE patients, NERD patients |
Primary outcome
The Number of Reflux in GERD Patients
Time frame: Day 4
We analyzed the number of acid and weakly acid reflux episodes in GERD patients
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21479676Zhong YQ, Lin Y, Xu Z. Expression of IFN-gamma and IL-4 in the esophageal mucosa of patients with reflux esophagitis and Barrett's esophagus and their relationship with endoscopic and histologic grading. Dig Dis Sci. 2011 Oct;56(10):2865-70. doi: 10.1007/s10620-011-1696-9. Epub 2011 Apr 9.
- Background: PubMed 21590343Kohata Y, Fujiwara Y, Machida H, Okazaki H, Yamagami H, Tanigawa T, Watanabe K, Watanabe T, Tominaga K, Wei M, Wanibuchi H, Arakawa T. Role of Th-2 cytokines in the development of Barrett's esophagus in rats. J Gastroenterol. 2011 Jul;46(7):883-93. doi: 10.1007/s00535-011-0405-y. Epub 2011 May 18.
- Background: PubMed 15842572Gough MD, Ackroyd R, Majeed AW, Bird NC. Prediction of malignant potential in reflux disease: are cytokine polymorphisms important? Am J Gastroenterol. 2005 May;100(5):1012-8. doi: 10.1111/j.1572-0241.2005.40904.x.
- Background: PubMed 11889061Fitzgerald RC, Onwuegbusi BA, Bajaj-Elliott M, Saeed IT, Burnham WR, Farthing MJ. Diversity in the oesophageal phenotypic response to gastro-oesophageal reflux: immunological determinants. Gut. 2002 Apr;50(4):451-9. doi: 10.1136/gut.50.4.451.
- I.M.Sechenov First Moscow State Medical University websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vladimir Ivashkin, MD,PhD,Prof. principal investigator
I.M. Sechenov First Moscow State Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper gastrointestinal endoscopy with biopsy and collection of refluxate and Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring in people with Gastroesophageal Reflux Disease (GERD), run by Ivashkin Vladimir Trofimovich at 2 sites 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 5 inclusion and 6 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2022). 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?
The Number of Reflux in GERD Patients (time frame: Day 4). 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 NCT02699060, which also lists 4 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 18 Feb 2022.