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Completed

NCT Number: NCT02699060

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I.M.Sechenov First Moscow State Medical University, Moscow, Russia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical (patients) part

  • Signed informed consent
  • Gender: Male or Female
  • Age: 18-65 years of age
  • Clinically and/or endoscopically confirmed diagnosis of GERD

Exclusion criteria

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

Treatment and study plan

Upper gastrointestinal endoscopy with biopsy and collection of refluxate

Procedure

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.

Other names: EGD (esophagogastroduodenoscopy) with esophagus biopsy

Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

Procedure

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.

Other names: HRM and 24-h esophageal pH monitoring

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ivashkin Vladimir Trofimovich

Other

Collaborators

  • Abbott

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2016
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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