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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

Tracking Information
First Submitted Date  ICMJE March 18, 2015
First Posted Date  ICMJE April 3, 2015
Last Update Posted Date December 11, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02407938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
discomfort on a VAS from 1-10 for each type of measurement [ Time Frame: 1 hour ]
Discomfort during different steps of the investigation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Including Liquid Swallows and a Solid Test Meal
Official Title  ICMJE Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Using a Test Meal
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Healthy
Intervention  ICMJE Other: Rice meal
Study Arms  ICMJE 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)
Intervention: Other: Rice meal
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2015)
73
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2015)
75
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02407938
Other Study ID Numbers  ICMJE KEK-ZH-Nr. 2013-0176
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Zurich
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP