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

Healthy Clinical Trial

— Rice  

Official title:

Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Using a Test Meal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407938
• Other study ID #: KEK-ZH-Nr. 2013-0176
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: December 10, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Health Directorate Zurich County (Gesundheitsdirektion Kanton Zürich)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Rice meal

Locations

Country	Name	City	State
Switzerland	Division of Gastroenterology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	discomfort on a VAS from 1-10 for each type of measurement	Discomfort during different steps of the investigation	1 hour