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

Cystic Fibrosis Clinical Trial

Official title: MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea

Status Completed

Clinical Trial Summary

*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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency
• Malabsorption Syndromes
• Pancreatic Insufficiency
• Steatorrhea

• NCT number: NCT00572975
• Study type: Interventional
• Source: Children's Hospital of Philadelphia
• Status: Completed
• Phase: Phase 4
• Start date: August 2006
• Completion date: March 2008