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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CSID Mutations Individual has one or more known CSID mutations.
Control Individual does not have any known CSID mutations.

Participant Flow:   Overall Study
    CSID Mutations   Control
STARTED   27   26 
COMPLETED   19 [1]   14 [1] 
NOT COMPLETED   8   12 
[1] Number of subjects who completed through study and qualify as evaluable



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CSID Mutations Individual has one or more known CSID mutations.
Control Individual does not have any known CSID mutations.
Total Total of all reporting groups

Baseline Measures
   CSID Mutations   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   26   53 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Inter-Quartile Range)
 8 
 (1 to 13) 
 10.5 
 (6.25 to 16) 
 9 
 (2 to 15) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  51.9%      16  61.5%      30  56.6% 
Male      13  48.1%      10  38.5%      23  43.4% 
Region of Enrollment 
[Units: Participants]
     
United States   27   26   53 


  Outcome Measures

1.  Primary:   Prevalence of CSID Genetic Variants   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Heather Smith, Director of One Patient Services
Organization: QOL Medical, LLC
phone: 919-832-4949
e-mail: hsmith@onepatientservices.com



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