Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea (MBT)

Children's Hospital of Philadelphia (CHOP)

Status and phase

Completed

Phase 4

Conditions

Pancreatic Insufficiency

Cystic Fibrosis

Treatments

Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00572975

2004-5-3733

Details and patient eligibility

About

*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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

8+ years old

Volunteers

Accepts Healthy Volunteers

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.