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Trial record 1 of 2 for:    "congenital sucrase-isomaltase deficiency"
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Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS) (CSID GPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01914003
Recruitment Status : Completed
First Posted : August 1, 2013
Results First Posted : October 10, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Arnold Palmer Hospital for Children
Texas Children's Hospital
Nationwide Children's Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
University of Mississippi Medical Center
Children's Hospital and Research Center at Oakland
Columbia University
Children's Hospital Los Angeles
Children's Hospital and Health System Foundation, Wisconsin
Children's Center for Digestive Healthcare, LLC
Massachusetts General Hospital
Duke University
Johns Hopkins University
Children's Hospital of Philadelphia
Children's Mercy Hospital
Children's Hospital Colorado
Riley Children's Hospital
Primary Children's Hospital
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
QOL Medical, LLC

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Congenital Sucrase-isomaltase Deficiency (CSID)
Enrollment 53

Recruitment Details  
Pre-assignment Details  
Arm/Group Title CSID Mutations Control
Hide Arm/Group Description Individual has one or more known CSID mutations. Individual does not have any known CSID mutations.
Period Title: Overall Study
Started 27 26
Completed 19 [1] 14 [1]
Not Completed 8 12
[1]
Number of subjects who completed through study and qualify as evaluable
Arm/Group Title CSID Mutations Control Total
Hide Arm/Group Description Individual has one or more known CSID mutations. Individual does not have any known CSID mutations. Total of all reporting groups
Overall Number of Baseline Participants 27 26 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
<=18 years
27
 100.0%
26
 100.0%
53
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 27 participants 26 participants 53 participants
8
(1 to 13)
10.5
(6.25 to 16)
9
(2 to 15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Female
14
  51.9%
16
  61.5%
30
  56.6%
Male
13
  48.1%
10
  38.5%
23
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 26 participants 53 participants
27 26 53
1.Primary Outcome
Title Prevalence of CSID Genetic Variants
Hide Description 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.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CSID Mutations Control
Hide Arm/Group Description:
Individual has one or more known CSID mutations.
Individual does not have any known CSID mutations.
Overall Number of Participants Analyzed 27 26
Measure Type: Number
Unit of Measure: Participants
27 0
Time Frame Monitoring for adverse events occurred throughout the study, but none were expected or reported as no study drug was involved and minimally invasive procedures were used to obtain genetic and breath samples.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CSID Mutations Control
Hide Arm/Group Description Individual has one or more known CSID mutations. Individual does not have any known CSID mutations.
All-Cause Mortality
CSID Mutations Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CSID Mutations Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CSID Mutations Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/26 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
As outlined in each Clinical Trial Agreement between Sponsor and PI.
Results Point of Contact
Name/Title: Heather Smith, Director of One Patient Services
Organization: QOL Medical, LLC
Phone: 919-832-4949
Responsible Party: QOL Medical, LLC
ClinicalTrials.gov Identifier: NCT01914003     History of Changes
Other Study ID Numbers: S2002
First Submitted: July 22, 2013
First Posted: August 1, 2013
Results First Submitted: July 7, 2016
Results First Posted: October 10, 2016
Last Update Posted: November 6, 2017