Trial Outcomes & Findings for Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease (NCT NCT01854242)

NCT ID: NCT01854242

Last Updated: 2020-07-28

Results Overview

Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-07-28

Participant Flow

Participant milestones

Participant milestones
Measure
Glycogen Storage Disease Type Ia Patients
The participants will have one blood draw for this study. The test will be performed on the blood.
Overall Study
STARTED
50
Overall Study
COMPLETED
50
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Glycogen Storage Disease Type Ia Patients
n=50 Participants
The participants will have one blood draw for this study. The test will be performed on the blood.
Age, Categorical
<=18 years
32 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
23 Participants
n=5 Participants
Sex: Female, Male
Male
27 Participants
n=5 Participants
Region of Enrollment
United States
50 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.

Outcome measures

Outcome measures
Measure
Glycogen Storage Disease Type Ia Patients
n=50 Participants
The participants will have one blood draw for this study. The test will be performed on the blood.
Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease
11 participants testing positive

Adverse Events

Glycogen Storage Disease Type Ia Patients

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

David A. Weinstein, MD, MMSc

University of Florida

Phone: 3522650855

Results disclosure agreements

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