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Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Plasticity and Its Correlation With Different Forms of Gastroesophageal Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699060
Recruitment Status : Unknown
Verified March 2016 by Ivashkin Vladimir Trofimovich, I.M. Sechenov First Moscow State Medical University.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ivashkin Vladimir Trofimovich, I.M. Sechenov First Moscow State Medical University

Brief Summary:
This study is proposed to evaluate the role of motoric dysfunctions and burden of different kinds of refluxate on immune cells and the subsequent course of the disease. This study also aims to establish a bridge between instrumental findings (pH-impedance test) and clinical assessments (FSSG questionnaire), aiming to facilitate the use of simple questionnaire techniques in the clinical setting in the future.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate Procedure: 24-h esophageal pH-impedance test with manometry-control of pH-transducer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Experimental Study to Determine the Effects of Refluxate (Human: Biliary, Gastric, Duodenogastric/Mixed) on Macrophage Phenotype and Macrophage Plasticity and Its Correlation With Different Forms of Gastroesophageal Reflux Disease (Non-erosive and Erosive) and Complications Thereof (Barrett's Esophagus): Motility Talent Group Study
Study Start Date : February 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD


Intervention Details:
  • Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate
    The procedure should be performed on an empty stomach standard technique of anesthesia;10% lidocaine solution). The examination includes analysis of esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects (erosions, ulcers, strictures, hemorrhages), as well as the appearance of the gastric and duodenal mucosa. . The modified Savary-Miller classification of esophagitis will be used to characterize changes in the esophageal mucosa. For morphological research and monocyte/macrophage phenotype assessment biopsy sampling of distal esophagus will be performed.
    Other Names:
    • EGD (esophagogastroduodenoscopy)
    • UGI endoscopy (upper gastrointestinal endoscopy)
  • Procedure: 24-h esophageal pH-impedance test with manometry-control of pH-transducer

    Procedure of pH impedancemetry includes intranasal introduction of a probe into oesophagus and connection of the probe with the recording device and 24-hour wearing of the probe.

    Installation of the probe is carried out on an empty stomach. 24-h pH-impedance monitoring will be done in both distal oesophagus and in the stomach according to standard of practice. Esophageal pH sensor will be positioned 5 cm above the manometrically located border of the lower esophageal sphincter. Measurement with a second pH sensor in the stomach, 10cm below the lower esophageal sphincter in order to monitor intragastric acidity will be done as a standard routine procedure.

    Standard measuring parameters will be collected: percent of time when pH is less than 4, total number of reflux episodes, number of acid and alkaline reflux episodes, duration of longest reflux episode.

    Other Name: 24-h Esophageal pH Monitoring


Primary Outcome Measures :
  1. Changes in macrophagal phenotype from baseline after exposure to three different forms of human refluxate (gastric, biliary, duodenogastric/mixed) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699060


Contacts
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Contact: Anna Paraskevova, MD paraskevova.anna@mail.ru

Locations
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Russian Federation
I.M.Sechenov First Moscow State Medical University Recruiting
Moscow, Russian Federation, 119991
Contact: Anna Paraskevova, MD       paraskevova.anna@mail.ru   
Principal Investigator: Vladimir Ivashkin, MD, PhD,Prof         
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov Recruiting
Moscow, Russian Federation, 127473
Contact: Svetlana Lyamina, MD,PhD       svlvs@mail.ru   
Principal Investigator: Igor Malyshev, MD,PhD,Prof         
Sponsors and Collaborators
Ivashkin Vladimir Trofimovich
Abbott
Investigators
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Principal Investigator: Vladimir Ivashkin, MD,PhD,Prof. I.M. Sechenov First Moscow State Medical University
Additional Information:
Publications:
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Responsible Party: Ivashkin Vladimir Trofimovich, MD, PhD, professor, head of department of propedeutics of internal diseases, director of clinic of propedeutics of internal diseases, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT02699060    
Other Study ID Numbers: EPIDKO19
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ivashkin Vladimir Trofimovich, I.M. Sechenov First Moscow State Medical University:
GERD
Barrett's esophagus
macrophage
FSSG questionnaire
Additional relevant MeSH terms:
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Barrett Esophagus
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Precancerous Conditions
Neoplasms