Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
Not provided
Not provided
Not provided
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional supplement for blood lipid levels, safety and tolerability compared to a standard of care nutritional supplement used concomitantly with PERT.
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional supplement for blood lipid levels, safety and tolerability compared to a standard of care nutritional supplement used concomitantly with PERT.
The study hypothesis is that the PERT-free nutritional supplement will be equivalent to, or superior to, a standardized nutritional shake with regard to fat absorption, as indicated by blood lipid (triglyceride) levels while maintaining tolerability and safety without the use of PERT. The objective is to evaluate efficacy, safety, and tolerability of a "PERT-free" nutritional shake compared to a standard nutritional shake used concomitantly with PERT. Measurements include components of a standard lipid blood panel (triglycerides, cholesterol, HDL cholesterol, LDL cholesterol, and VLDL cholesterol), absorption of fat-soluble vitamins (vitamin D) and symptoms associated with EPI. Other objectives include evaluating palatability and patients' impressions of the products.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBNS + PERT placebo | Experimental | GBNS + PERT placebo (drink volume sufficient to supply 0.5 g of MAG per kg of body weight plus PERT placebo capsules according to patient body weight. |
|
| Standard Nutritional Supplement + PERT | Active Comparator | Standard nutritional supplement + PERT (drink volume sufficient to supply 0.5 g of TAG per kg of body weight plus PERT capsules according to body weight). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlycosBio Nutritional Supplement + PERT placebo | Dietary Supplement | The lipid (fat) in the GlycosBio Nutritional Supplement (GBNS) was provided in the form of a re-structured lipid monoacylglyceride (MAG) produced by the study sponsor. MAGs are readily absorbed by enterocytes without the need of digestion by pancreatic lipases. The "MAG oil" is produced enzymatically from almond oil. The product also contains essential amino acids, carbohydrates as simple sugars and fat-soluble vitamins and minerals. The GBNS to be administered in a volume sufficient to supply 0.5 g of MAG per kg of body weight |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum triglyceride concentration | Maximum change from baseline for serum triglyceride concentration based on an hourly blood draw over a 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| Maximum serum triglyceride concentration | Maximum serum triglyceride concentration during the 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| Area under the curve (AUC) for triglyceride serum levels | Incremental area under the curve (AUC) for triglyceride serum levels during the 6 hour time period following following administration of the oral nutritional supplement. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serum glucose | Maximum change from baseline for serum serum glucose based on an hourly blood draw over a 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| Total cholesterol |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability | Differences in the palatability of each oral nutritional supplement assessed via a participant survey. | 6 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center (CRC) at Texas Children's Hospital | Houston | Texas | 77030 | United States |
Not provided
| 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 |
Not provided
Not provided
Single center, randomized, double-blind, cross-over trial with a single blind stage evaluation assessing the GBNS for safety, tolerability and blood lipid levels compared to a standard nutritional supplement with PERT. Phase 1: After an overnight fast, subjects in Arm 1 administered PERT placebo with the GBNS and those in Arm 2 will be administered standard nutritional supplement with PERT. Blood samples collected at baseline and hourly over 6 hours for all subjects. Subjects will return for crossover treatment no fewer than 4 days and no more than 14 days after with the same steps as the above but with patients switching treatment arms. Phase 2: Starting the day following the 2nd treatment the 6 day, single-blind safety stage begins with subjects randomized to GBNS with PERT-placebo or the standard nutritional supplement with PERT. One week after the end of the Home Trial (+/- 3 days) patients will return for an end of study visit.
Not provided
Not provided
Not provided
|
| Standard Nutritional Supplement + PERT | Dietary Supplement | A 5.9% fat triacylglycerol-based commercially available nutritional supplement (Boost Plus®, Nestlé Health Science, Bridgewater, NJ) in a volume sufficient to supply 0.5 g of TAG per kg of body weight over the same time period and PERT capsules (24,000 iu/capsule) at a dose of 2,500 iu of lipase activity per gram of fat ingested. |
|
Maximum change from baseline for serum total cholesterol based on an hourly blood draw over a 6 hour period following administration of the oral nutritional supplement.
| 6 hours |
| HDL cholesterol | Maximum change from baseline for serum HDL cholesterol based on an hourly blood draw over a 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| LDL cholesterol | Maximum change from baseline for serum LDL cholesterol based on an hourly blood draw over a 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| VLDL cholesterol | Maximum change from baseline for serum VLDL cholesterol based on an hourly blood draw over a 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| Incidence of gastrointestinal (GI) symptoms | Incidence of gastrointestinal (GI) symptoms including nausea, heartburn, abdominal pain, steatorrhea, bloating and other reported symptoms over a 6 hour period following administration of the oral nutritional supplement. | 6 hours |
| Number of stools and other abdominal symptoms | Average daily number of stools and the percentage of days with 1) hard or formed/normal or soft stools, 2) no steatorrhea, 3) no abdominal pain, and 4) no bloating during the 6 days during Phase II (home phase) of trial. | 6 days |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |