Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
GERD, Barrett's esophagus, macrophage, FSSG questionnaire
Brief 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.
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).
Interventions
PROCEDUREUpper gastrointestinal endoscopy with biopsy and collection of refluxate
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.
PROCEDUREEsophageal high-resolution manometry and 24-h esophageal pH-impedance 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.
Sponsors
Abbott
Ivashkin Vladimir Trofimovich
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Clinical (patients) part 1. Signed informed consent 2. Gender: Male or Female 3. Age: 18-65 years of age 3\. Clinically and/or endoscopically confirmed diagnosis of GERD
Exclusion criteria
Clinical: (patient) 1. 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. 2. Female patients who are pregnant, planning to become pregnant or lactating 3. 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. 4. Participation in a clinical trial in the past 3 months 5. Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Reflux in GERD Patients | Day 4 | We analyzed the number of acid and weakly acid reflux episodes in GERD patients |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non Erosive Reflux Disease Participants not received drugs | 28 |
| Erosive Esophagitis Participants not received drugs | 22 |
| Barrett's Esophagus Participants not received drugs | 18 |
| Total | 68 |
Baseline characteristics
| Characteristic | Non Erosive Reflux Disease | Erosive Esophagitis | Barrett's Esophagus | Total |
|---|---|---|---|---|
| Age, Continuous | 45.74 years STANDARD_DEVIATION 2.23 | 45.0 years STANDARD_DEVIATION 3.24 | 47.22 years STANDARD_DEVIATION 2.95 | 46.8 years STANDARD_DEVIATION 12.4 |
| Expression levels macrophage CD markers from GERD patients CD163 | 16.6 mg/l STANDARD_DEVIATION 15.9 | 18.0 mg/l STANDARD_DEVIATION 10 | 14.3 mg/l STANDARD_DEVIATION 8.1 | 16.3 mg/l STANDARD_DEVIATION 9.1 |
| Expression levels macrophage CD markers from GERD patients CD206 | 10.4 mg/l STANDARD_DEVIATION 7.2 | 11.9 mg/l STANDARD_DEVIATION 8 | 9.6 mg/l STANDARD_DEVIATION 7.7 | 10.6 mg/l STANDARD_DEVIATION 7.5 |
| Expression levels macrophage CD markers from GERD patients CD25 | 34.6 mg/l STANDARD_DEVIATION 15.9 | 34.2 mg/l STANDARD_DEVIATION 14 | 40.0 mg/l STANDARD_DEVIATION 14.4 | 36.9 mg/l STANDARD_DEVIATION 15.2 |
| Expression levels macrophage CD markers from GERD patients CD80 | 23.0 mg/l STANDARD_DEVIATION 13.3 | 23.5 mg/l STANDARD_DEVIATION 10 | 24.4 mg/l STANDARD_DEVIATION 11.5 | 23.4 mg/l STANDARD_DEVIATION 11.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Russia | 28 Participants | 22 Participants | 18 Participants | 68 Participants |
| Sex: Female, Male Female | 14 Participants | 7 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 13 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 22 | 0 / 18 |
| other Total, other adverse events | 0 / 28 | 0 / 22 | 0 / 18 |
| serious Total, serious adverse events | 0 / 28 | 0 / 22 | 0 / 18 |
Outcome results
Primary
The Number of Reflux in GERD Patients
We analyzed the number of acid and weakly acid reflux episodes in GERD patients
Time frame: Day 4
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NERD Patients | The Number of Reflux in GERD Patients | The acid reflux episodes | 33.6 episodes |
| NERD Patients | The Number of Reflux in GERD Patients | The weakly acid reflux episodes | 53.1 episodes |
| EE Patients | The Number of Reflux in GERD Patients | The acid reflux episodes | 42.8 episodes |
| EE Patients | The Number of Reflux in GERD Patients | The weakly acid reflux episodes | 34.4 episodes |
| BE Patients | The Number of Reflux in GERD Patients | The acid reflux episodes | 81.0 episodes |
| BE Patients | The Number of Reflux in GERD Patients | The weakly acid reflux episodes | 31.8 episodes |
p-value: 0.002Mixed Models Analysis