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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572975
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : September 30, 2008
Solvay Pharmaceuticals
Information provided by:
Children's Hospital of Philadelphia

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pancreatic Insufficiency Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Aim 1:Comparing Gastric Emptying and Small Bowel Transit Protocol in Healthy Controls [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572975

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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
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Principal Investigator: Maria Mascarenhas, M.D. Children's Hospital of Philadelphia

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Responsible Party: Maria R. Mascarenhas, M.D., The Children's Hospital of Philadelphia Identifier: NCT00572975     History of Changes
Other Study ID Numbers: 2004-5-3733
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008
Keywords provided by Children's Hospital of Philadelphia:
New diagnostic test for Cystic Fibrosis.
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Malabsorption Syndromes
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases