N/A N=68 Other

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

Gastroesophageal Reflux Disease (GERD)

Bottom Line

View on ClinicalTrials.gov: NCT02699060 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2022

Primary outcome: Primary: The Number of Reflux in GERD Patients — 33.6; 42.8; 81.0; 53.1 episodes — p=0.002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Upper gastrointestinal endoscopy with biopsy and collection of refluxate (Procedure); Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ivashkin Vladimir Trofimovich
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Reflux in GERD Patients	33.6; 42.8; 81.0; 53.1; 34.4; 31.8	0.002 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02699060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.