NCT02699060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

February 12, 2016

Results QC Date

February 11, 2020

Last Update Submit

February 17, 2022

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERDBarrett's esophagusmacrophageFSSG questionnaire

Outcome Measures

Primary Outcomes (1)

  • The Number of Reflux in GERD Patients

    We analyzed the number of acid and weakly acid reflux episodes in GERD patients

    Day 4

Study Arms (3)

NERD patients

EXPERIMENTAL

Patients have typical reflux syndrome without esophageal injury.

Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxateProcedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

EE patients

EXPERIMENTAL

Patients have erosion(s) or ulcer(s) in esophagus.

Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxateProcedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

BE patients

EXPERIMENTAL

Patients have esophageal specialized intestinal metaplasia.

Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxateProcedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

Interventions

Upper gastrointestinal endoscopy with biopsy and collection of refluxatePROCEDURE

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.

Also known as: EGD (esophagogastroduodenoscopy) with esophagus biopsy
BE patientsEE patientsNERD patients
Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringPROCEDURE

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.

Also known as: HRM and 24-h esophageal pH monitoring
BE patientsEE patientsNERD patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical (patients) part
  • Signed informed consent
  • Gender: Male or Female
  • Age: 18-65 years of age
  • \. Clinically and/or endoscopically confirmed diagnosis of GERD

You may not qualify if:

  • Clinical: (patient)
  • Female patients who are pregnant, planning to become pregnant or lactating
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

I.M.Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

Moscow, 127473, Russia

Location

Related Publications (4)

  • Zhong 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: 21479676BACKGROUND

  • 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.

    PMID: 21590343BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.2005.40904.x.

    PMID: 15842572BACKGROUND

  • 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. doi: 10.1136/gut.50.4.451.

    PMID: 11889061BACKGROUND

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxBarrett Esophagus

Interventions

Endoscopy, Digestive SystemBiopsy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPrecancerous ConditionsNeoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingInvestigative Techniques

Results Point of Contact

Title
MD, PhD Ivashkin Vladimir Trofimovich
Organization
IMSechenovMMA
motility_2013@mail.ru
+79252667987

Study Officials

  • Vladimir Ivashkin, MD,PhD,Prof.

    I.M. Sechenov First Moscow State Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, professor, head of department of propedeutics of internal diseases, director of clinic of propedeutics of internal diseases

Study Record Dates

First Submitted

February 12, 2016

First Posted

March 4, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 18, 2022

Results First Posted

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(2)