Breath and Blood Ammonia Response to an Oral Protein Challenge
NCT ID: NCT02650245
Last Updated: 2016-10-13
Study Results
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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COMPLETED
NA
12 participants
INTERVENTIONAL
2015-10-31
2016-04-30
Brief Summary
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Detailed Description
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The present protocol attempts to address both concerns and build upon the investigators prior high protein experience. By using a standard moderate protein challenge, the investigators can evaluate the breath ammonia responsiveness in healthy subjects and those with cirrhosis. This protocol leverages the power of breath research to evaluate responses to oral challenges. This remains a key asset of breath research.
Since the protocol proposes a moderate protein challenge, the investigators can evaluate disease states with minimal or no risk. As with past high protein studies, lactulose (10gm) will still be added to provoke a hydrogen response.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Moderate protein and 10gm lactulose
40% of daily recommended intake of protein based on weight
EAS Myoplex Protein Drink + 10gm lactulose
Interventions
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EAS Myoplex Protein Drink + 10gm lactulose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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St. Luke's Hospital and Health Network, Pennsylvania
OTHER
Responsible Party
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Dr. Steve Solga
M.D.
Principal Investigators
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Steve Solga, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Luke's University Hospital and Health Network
Locations
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St. Luke's University Hospital and Health Network
Bethlehem, Pennsylvania, United States
Countries
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Other Identifiers
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2015-59
Identifier Type: -
Identifier Source: org_study_id
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