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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Rice meal

• Registration Number: NCT02407938
• Lead Sponsor: University of Zurich

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Healthy volunteers without gastrointestinal co-morbidity

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rice meal	Rice meal	High resolution manometry will be performed. Esophageal function will be tested using liquid swallows, solid swallows and a test meal (200g rice)

Primary Outcome Measures

Name	Time	Method
Values for HRM data (IRP, DCI, DL) in healthy volunteers	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

Name	Time	Method
discomfort on a VAS from 1-10 for each type of measurement	1 hour	Discomfort during different steps of the investigation

Trial Locations

Locations (1)

Division of Gastroenterology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland