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Breath and Blood Ammonia Response to an Oral Protein Challenge

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EAS Myoplex Protein Drink + 10gm lactulose
Sponsored by
St. Luke's Hospital and Health Network, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring breath, gastroenterology, ammonia, blood, protein, cirrhosis, encephalopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • <18 and <75 yrs of age

Exclusion Criteria:

  • Diabetic, smoker, substance abuse

Sites / Locations

  • St. Luke's University Hospital and Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moderate protein and 10gm lactulose

Arm Description

40% of daily recommended intake of protein based on weight

Outcomes

Primary Outcome Measures

Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor
Evaluating change in breath ammonia at hour 5 compared to baseline

Secondary Outcome Measures

Full Information

First Posted
October 15, 2015
Last Updated
October 12, 2016
Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02650245
Brief Title
Breath and Blood Ammonia Response to an Oral Protein Challenge
Official Title
Breath and Blood Ammonia Response to an Oral Protein Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital and Health Network, Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators specific aim is to evaluate the changes in breath ammonia in comparison to blood ammonia and other physiologic markers after a moderate oral protein challenge in healthy subjects and subjects with liver cirrhosis.
Detailed Description
Ammonia is an important molecule relevant to numerous diseases, especially to the millions of patients with cirrhosis worldwide. Venous blood ammonia via limb phlebotomy, can at best roughly estimate whole body ammonia, but says little or nothing about intestinal production, and cannot "source" ammonia to any particular organ or body compartment. Unfortunately, there are no presently available better tests. Therefore, despite these acknowledged limitations, venous ammonia the "bronze standard" benchmark by which new metrics are assessed. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
breath, gastroenterology, ammonia, blood, protein, cirrhosis, encephalopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate protein and 10gm lactulose
Arm Type
Experimental
Arm Description
40% of daily recommended intake of protein based on weight
Intervention Type
Dietary Supplement
Intervention Name(s)
EAS Myoplex Protein Drink + 10gm lactulose
Primary Outcome Measure Information:
Title
Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor
Description
Evaluating change in breath ammonia at hour 5 compared to baseline
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: <18 and <75 yrs of age Exclusion Criteria: Diabetic, smoker, substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Solga, M.D.
Organizational Affiliation
St. Luke's University Hospital and Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's University Hospital and Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States

12. IPD Sharing Statement

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Breath and Blood Ammonia Response to an Oral Protein Challenge

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