NCT02650245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

October 15, 2015

Last Update Submit

October 12, 2016

Conditions

Cirrhosis

Keywords

breathgastroenterologyammoniabloodproteincirrhosisencephalopathy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Moderate protein and 10gm lactulose

EXPERIMENTAL

40% of daily recommended intake of protein based on weight

Dietary Supplement: EAS Myoplex Protein Drink + 10gm lactulose

Interventions

EAS Myoplex Protein Drink + 10gm lactuloseDIETARY_SUPPLEMENT
Moderate protein and 10gm lactulose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<18 and \<75 yrs of age

You may not qualify if:

  • Diabetic, smoker, substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's University Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

FibrosisBrain Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Steve Solga, M.D.

    St. Luke's University Hospital and Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 15, 2015

First Posted

January 8, 2016

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)