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

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

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 months

Population: each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption

72 hour fat absorption study

Outcome measures

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

Stephen O'Keefe

University of Pittsburgh

Phone: 412 648 7217

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place