Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea - Full Text View

Sponsor:	Children's Hospital of Philadelphia
Collaborator:	Solvay Pharmaceuticals
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00572975

Purpose

The purpose of this study is to develop a more accurate, reliable, specific and more acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying fat malabsorption in people with CF and pancreatic insufficiency.

Condition	Intervention	Phase
Cystic Fibrosis Pancreatic Insufficiency	Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA)	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

Aim 1:Comparing Gastric Emptying and Small Bowel Transit Protocol in Healthy Controls [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Aim 2:The results will establish which pattern of timing of enzyme ingestion results in optimal fat absorption of PA and HA. The results will also elucidate the role of gastric emptying and small bowel transit in subjects in CF. [ Time Frame: 12-hour fast on 4 separate occasions, each at least 5 days apart ] [ Designated as safety issue: No ]
Aim 3: The results will establish the reproducibility of MBT as well as estimate the fecal loss of odd chain fatty acids (PA & THA) [ Time Frame: 12-hour fast on three separate occasions, each at least 5 days apart ] [ Designated as safety issue: No ]
Aim 4: Dosage Titration Protocol is being tested in order to see changes in absorption with MBT [ Time Frame: 12-hour fast on two separate occasions ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	August 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA) Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption. in breakfast shake x1

Detailed Description:

Nine subjects with CF will be recruited to complete the MBT on two separate occasions, with different doses of pancreatic enzymes
At each MBT visit, subjects will receive a specific enzyme dose just before they drink the test meal (shake)
Fat absorption is maximized when the enzymes are taken with the shake.
If subjects usually receive brands of pancreatic enzymes different from Creon, their dose will be converted to an equivalent dose of Creon 20 for the study.

Prior to each study visit all subjects will be required to:

Eat their usual diet for 2 days prior to MBT
Refrain from consuming alcohol or dairy products for 24 hours prior to MBT
Refrain from non-routine physical exercise for 20 hours prior to MBT
Adhere to a 12-hour fast prior to MBT (from 8 PM previous night)
Can drink water from 8:00 PM on the night before the test to 2:00 AM on the day of the test
At visits 1 and 2, blood samples will be obtained at hourly intervals over a period of eight hours.
Samples will be analyzed for PA, HA and Triglyceride concentrations.
Patients will be permitted to ingest non-caloric and non-caffeinated beverages.
At hour 6, patients will be provided 1000 Kcal, low fat (12 grams of fat) lunch meal.

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects with cystic fibrosis and pancreatic insufficiency (n=9), 8 years of age or older, in usual state of good health will be eligible to participate in this Aim.
Subjects will be screened for genotype and a history of pancreatic insufficiency (PI). PI will be confirmed by measurement of fecal elastase 1< 200 mg/g stool.

Exclusion Criteria:

Subjects will be ineligible if they have an FEV1 % predicted of < 40%, a history of fibrosing colonopathy or any significant bowel resection (>10 cm) with the exception of a routine, uncomplicated appendectomy.
Subjects with diabetes mellitus or disorders associated with altered energy metabolism (i.e. hypothyroidism), or any major illnesses that affect the gastrointestinal tract, will not be eligible for the study.
Subjects with significant liver disease, or significant developmental delay will also be excluded.
Subjects will be excluded if they have a food allergy related to any components of the experimental shake (i.e., soy or chocolate) or the stool marker, carmine red.
Subjects who are pregnant are not eligible. Subjects with a history of intolerance or allergy to Creon 20 will be excluded from the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572975

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399

Sponsors and Collaborators

Children's Hospital of Philadelphia

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Maria Mascarenhas, M.D.

Children's Hospital of Philadelphia

More Information

No publications provided

Responsible Party:	The Children's Hospital of Philadelphia ( Maria R. Mascarenhas, M.D. )
Study ID Numbers:	2004-5-3733
Study First Received:	December 11, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00572975 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

New diagnostic test for Cystic Fibrosis.

Additional relevant MeSH terms:

Metabolic Diseases
Gastrointestinal Diseases
Fibrosis
Intestinal Diseases
Digestive System Diseases
Pathologic Processes
Cystic Fibrosis
Respiratory Tract Diseases

Genetic Diseases, Inborn
Lung Diseases
Malabsorption Syndromes
Pancreatic Diseases
Infant, Newborn, Diseases
Exocrine Pancreatic Insufficiency
Steatorrhea

ClinicalTrials.gov processed this record on November 25, 2009