Clinical trial · Interventional
Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD
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
NCT02699060CI-TRIAL-00056610completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Reflux Disease (GERD) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring | Procedure | — | UNRESOLVED |
| Upper gastrointestinal endoscopy with biopsy and collection of refluxate | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NERD patients
- description
- Patients have typical reflux syndrome without esophageal injury.
- interventionNames
- Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate
- Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
- type
- EXPERIMENTAL
- label
- EE patients
- description
- Patients have erosion(s) or ulcer(s) in esophagus.
- interventionNames
- Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate
- Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDZhong 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. PMID 21479676
- BACKGROUNDKohata 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. PMID 21590343
- BACKGROUNDGough 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. PMID 15842572
- BACKGROUNDFitzgerald 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. PMID 11889061