Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699060
• Other study ID #: EPIDKO19
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 2019

Study information

• Verified date: February 2022
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Procedure:
• Upper 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.
• Esophageal 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.

Locations

Country	Name	City	State
Russian Federation	I.M.Sechenov First Moscow State Medical University	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry named after A.I. Evdokimov	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Ivashkin Vladimir Trofimovich	Abbott

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

Fitzgerald 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. — View Citation

Gough 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. — View Citation

Kohata 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. — View Citation

Zhong YQ, Lin Y, Xu Z. Expression of IFN-? 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Reflux in GERD Patients	We analyzed the number of acid and weakly acid reflux episodes in GERD patients	Day 4

External Links

•   I.M.Sechenov First Moscow State Medical University website