Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea (MBT)
|ClinicalTrials.gov Identifier: NCT00572975|
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : September 30, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Pancreatic Insufficiency||Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA)||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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
- Aim 1:Comparing Gastric Emptying and Small Bowel Transit Protocol in Healthy Controls [ Time Frame: 72 hours ]
- 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 ]
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572975
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4399|
|Principal Investigator:||Maria Mascarenhas, M.D.||Children's Hospital of Philadelphia|