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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
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*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.
Prior to each study visit all subjects will be required to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentadecanoic acid (PA) and Triheptadecanoin (THA) | Other | Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption. in breakfast shake x1 |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1:Comparing Gastric Emptying and Small Bowel Transit Protocol in Healthy Controls | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-hour fast on 4 separate occasions, each at least 5 days apart | |
| Aim 3: The results will establish the reproducibility of MBT as well as estimate the fecal loss of odd chain fatty acids (PA & THA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Mascarenhas, M.D. | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4399 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C117025 | pentadecanoic acid |
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| 12-hour fast on three separate occasions, each at least 5 days apart |
| Aim 4: Dosage Titration Protocol is being tested in order to see changes in absorption with MBT | 12-hour fast on two separate occasions |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |