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Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Including Liquid Swallows and a Solid Test Meal (Rice)

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ClinicalTrials.gov Identifier: NCT02407938
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal and a postprandial observational period will be determined.

Condition or disease Intervention/treatment Phase
Healthy Other: Rice meal Not Applicable

Detailed Description:
The investigators will recruit healthy volunteers and ask for study participation. After providing informed consent, participants will be questioned using standardized questionnaires assessing symptoms of reflux, dysphagia, gastrointestinal symptom burden and depression. Participants will be tested using our advanced protocol for high resolution esophageal manometry. This protocol includes individual liquid swallows, free drinking of water, a standardized test meal (200g rice) and a postprandial observational period. Normal values for liquid and solid swallows will be determined.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Using a Test Meal
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: rice meal
High resolution manometry will be performed. Esophageal function will be tested using liquid swallows, solid swallows and a test meal (200g rice)
 Other: Rice meal


Outcome Measures
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Primary Outcome Measures :
  1. Values for HRM data (IRP, DCI, DL) in healthy volunteers [ Time Frame: 1 hour ]
    Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal


Secondary Outcome Measures :
  1. discomfort on a VAS from 1-10 for each type of measurement [ Time Frame: 1 hour ]
    Discomfort during different steps of the investigation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers without gastrointestinal co-morbidity

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent
  • Any relevant current or past gastrointestinal morbidity (including diseases relevant previous surgery).
  • Relevant gastrointestinal symptoms
  • Relevant medication (as specified below) within the last 4 weeks
  • Age below 18 years
Contacts and Locations
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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): NCT02407938


Locations
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Switzerland
Division of Gastroenterology, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02407938     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2013-0176
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by University of Zurich:
dysphagia
reflux symptoms
retrosternal pain