Trial Outcomes & Findings for Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS) (NCT NCT01914003)
NCT ID: NCT01914003
Last Updated: 2017-11-06
Results Overview
Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.
Recruitment status
COMPLETED
Target enrollment
53 participants
Primary outcome timeframe
1 year
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
CSID Mutations
Individual has one or more known CSID mutations.
|
Control
Individual does not have any known CSID mutations.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
19
|
14
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS)
Baseline characteristics by cohort
| Measure |
CSID Mutations
n=27 Participants
Individual has one or more known CSID mutations.
|
Control
n=26 Participants
Individual does not have any known CSID mutations.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8 years
n=5 Participants
|
10.5 years
n=7 Participants
|
9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPrevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.
Outcome measures
| Measure |
CSID Mutations
n=27 Participants
Individual has one or more known CSID mutations.
|
Control
n=26 Participants
Individual does not have any known CSID mutations.
|
|---|---|---|
|
Prevalence of CSID Genetic Variants
|
27 Participants
|
0 Participants
|
Adverse Events
CSID Mutations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Heather Smith, Director of One Patient Services
QOL Medical, LLC
Phone: 919-832-4949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee As outlined in each Clinical Trial Agreement between Sponsor and PI.
- Publication restrictions are in place
Restriction type: OTHER