Status:
COMPLETED
Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function
Lead Sponsor:
Texas A&M University
Collaborating Sponsors:
Arkansas Children's Hospital Research Institute
University of Arkansas
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An impaired intestinal digestion and absorption capacity is one of the main factors responsible for the malnutri...
Eligibility Criteria
Inclusion
- Adult subjects with CF
- Diagnosis of CF based on universal diagnostic criteria
- Pancreatic insufficiency based on clinical diagnosis
- Abnormal lipid digestion requiring pancreatic enzyme replacement therapy
- Age is 18 years and older.
- Admitted to UAMS for treatment of exacerbations of CF (inpatients) or under routine medical control at the CF center of UAMS
- Clinically stable CF at the time of enrollment
- Healthy adults
- Age is 18 years and older at the time of enrollment.
- BMI between 18 and 35 kg/m2
Exclusion
- Pediatric and adult CF groups
- Unstable metabolic diseases including liver (cirrhosis) or renal disease
- Chronic respiratory failure with cor pulmonale
- Any other condition according to the principle investigator or study physician would interfere with proper conduct of study / safety of the patient
- Failure to give assent / informed consent
- Diagnosis of severe lung disease, defined as FEV1 \< 35% predicted
- Healthy adults
- Presence of acute or chronic unstable diseases such as liver, renal, heart or lung disease
- Previous surgery less than 4 weeks prior to the experiment
- Recent involuntary weight loss (\>10% in the past 3 months)
- Any documented autoimmune disease
- Any other condition according to the principle investigator or study physician would interfere with collecting study samples
- Failure to give informed consent
Key Trial Info
Start Date :
November 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01494909
Start Date
November 15 2010
End Date
December 7 2011
Last Update
October 1 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205