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OpenTrials
Completed

NCT Number: NCT02407938

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

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.

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Key information

Conditions

Healthy Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rice meal

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. discomfort on a VAS from 1-10 for each type of measurement

    Time frame: 1 hour

    Discomfort during different steps of the investigation

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: Rice

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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