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

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00572975
First received: December 11, 2007
Last updated: September 26, 2008
Last verified: September 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea

Resource links provided by NLM:


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Maria R. Mascarenhas, M.D., The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00572975     History of Changes
Other Study ID Numbers: 2004-5-3733
Study First Received: December 11, 2007
Last Updated: September 26, 2008
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:
Cystic Fibrosis
Fibrosis
Malabsorption Syndromes
Exocrine Pancreatic Insufficiency
Steatorrhea
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014