Breath and Blood Ammonia Response to an Oral Protein Challenge



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:September 2015
End Date:July 2016
Contact:Arthur Strzepka, B.A.
Email:arthur.strzepka@gmail.com

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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.

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.

Inclusion Criteria:

- <18 and <75 yrs of age

Exclusion Criteria:

- Diabetic, smoker, substance abuse
We found this trial at
1
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Bethlehem, Pennsylvania 18017
Phone: 610-866-3900
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Bethlehem, PA
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