Trial Outcomes & Findings for Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients (NCT NCT00510744)
NCT ID: NCT00510744
Last Updated: 2016-06-02
Results Overview
72 hour fat absorption study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
3 months
Results posted on
2016-06-02
Participant Flow
Participant milestones
| Measure |
Pancreatic Enzyme Supplementation
3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
pancreatic enzyme supplement: 4 caps with meals, 2 with snacks
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Baseline characteristics by cohort
| Measure |
Pancreatic Enzyme Supplementation
n=5 Participants
3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
pancreatic enzyme supplement: 4 caps with meals, 2 with snacks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption
72 hour fat absorption study
Outcome measures
| Measure |
Pancreatic Enzyme Supplementation
n=5 Participants
3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption
|
|---|---|
|
Fat Absorption
|
60.6 g/d
Standard Error 13.4
|
Adverse Events
Pancreatic Enzyme Supplementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place