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

NCT ID: NCT02407938

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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dysphagia reflux symptoms retrosternal pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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rice meal

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

Group Type EXPERIMENTAL

Rice meal

Intervention Type OTHER

Interventions

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Rice meal

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Gastroenterology, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 28684262 (View on PubMed)

Hollenstein 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.

Reference Type DERIVED
PMID: 28684261 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2013-0176

Identifier Type: -

Identifier Source: org_study_id