Breath and Blood Ammonia Response to an Oral Protein Challenge

Cirrhosis Clinical Trial

Official title:

Breath and Blood Ammonia Response to an Oral Protein Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650245
• Other study ID #: 2015-59
• Status: Completed
• Phase: N/A
• First received: October 15, 2015
• Last updated: October 12, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: St. Luke's Hospital and Health Network, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• <18 and <75 yrs of age

Exclusion Criteria:

• Diabetic, smoker, substance abuse

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

Dietary Supplement:
• EAS Myoplex Protein Drink + 10gm lactulose

Locations

Country	Name	City	State
United States	St. Luke's University Hospital and Health Network	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital and Health Network, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 hours	No