Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Including Liquid Swallows and a Solid Test Meal
Rice
1 other identifier
interventional
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jan 2014
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 11, 2015
December 1, 2015
1.4 years
March 18, 2015
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Values for HRM data (IRP, DCI, DL) in healthy volunteers
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
1 hour
Secondary Outcomes (1)
discomfort on a VAS from 1-10 for each type of measurement
1 hour
Study Arms (1)
rice meal
EXPERIMENTALHigh resolution manometry will be performed. Esophageal function will be tested using liquid swallows, solid swallows and a test meal (200g rice)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers without gastrointestinal co-morbidity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology, University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (2)
Ang D, Misselwitz B, Hollenstein M, Knowles K, Wright J, Tucker E, Sweis R, Fox M. Diagnostic yield of high-resolution manometry with a solid test meal for clinically relevant, symptomatic oesophageal motility disorders: serial diagnostic study. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):654-661. doi: 10.1016/S2468-1253(17)30148-6. Epub 2017 Jul 3.
PMID: 28684262DERIVEDHollenstein M, Thwaites P, Butikofer S, Heinrich H, Sauter M, Ulmer I, Pohl D, Ang D, Eberli D, Schwizer W, Fried M, Distler O, Fox M, Misselwitz B. Pharyngeal swallowing and oesophageal motility during a solid meal test: a prospective study in healthy volunteers and patients with major motility disorders. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):644-653. doi: 10.1016/S2468-1253(17)30151-6. Epub 2017 Jul 3.
PMID: 28684261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2015
First Posted
April 3, 2015
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 11, 2015
Record last verified: 2015-12