Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea (MBT)
This study has been completed.
Sponsor:
Children's Hospital of Philadelphia
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
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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
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 May 19, 2013