Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS) Status: Recruiting Study Phase: N/A Start Date: May 2013 | Completion Date: May 2015 Condition(s): Congenital Sucrase-isomaltase Deficiency (CSID) Full Title of Study A Multi-Center Study of the Prevalence of Known Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Variants and Functional Sucrase Activity by 13C-Sucrose Breath Test in Children With Chronic Diarrhea or Chronic Abdominal Pain Overview Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which mutations in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting in diarrhea and abdominal pain. Children with chronic, idiopathic diarrhea or abdominal pain will have their sucrose-isomaltase gene assessed for a panel of known CSID mutations to determine the prevalence of these mutations in an enriched population and also determine functional deficiency using a breath test.
Study Details Study Type: Observational Study Design: Observational Model: Case Control, Time Perspective: Prospective
Investigator Details Lead Sponsor: QOL Medical, LLC Collaborator: Arnold Palmer Hospital for Children Collaborator: Texas Children's Hospital Collaborator
: Nationwide Children's Hospital Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago Collaborator: University of Mississippi Medical Center Collaborator: Children's Hospital and Research Center at Oakland Collaborator: Morgan Stanley Children's Hospital Collaborator: Children's Hospital Los Angeles Collaborator: Children's Hospital and Health System Foundation, Wisconsin Collaborator: Children's Center for Digestive Healthcare Collaborator: Massachusetts General Hospital Collaborator: Duke University Children's Hospital Collaborator: Johns Hopkins University Collaborator: Children's Hospital of Philadelphia Collaborator: Children's Mercy Hospital Collaborator: Children's Hospital Colorado Collaborator: Riley Hospital for Children Collaborator: Primary Children's Hospital Collaborator: State University of New York - Downstate Medical Center
Trial Location Details Facility: Children's Hospital Los Angeles Los Angeles, United States Principal Investigator: Jaya Punati, MD Facility: Children's Hospital and Research Center of Oakland Oakland, United States Principal Investigator: Mala Setty, MD Facility: Children's Hospital of Colorado Aurora, United States Principal Investigator: Joel Friedlander, MD Facility: Arnold Palmer Children's Hospital Orlando, United States Principal Investigator: Devendra Mehta, MD Facility: Children's Center for Digestive Healthcare Atlanta, United States
Principal Investigator: Jeffrey Lewis, MD Facility: Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, United States Principal Investigator: Miguel Saps, MD Facility: Riley Hospital for Children Indianapolis, United States Principal Investigator: Sandeep Gupta, MD Facility: Johns Hopkins Children's Center Baltimore, United States Principal Investigator: Ann Scheimann, MD Facility: Massachusetts General Hospital Boston, United States Principal Investigator: Aeri Moon, MD Facility: University of Mississippi Medical Center Jackson, United States Principal Investigator: Neelesh Tipnis, MD Facility: Children's Mercy Hospital Kansas City, United States Principal Investigator: Joel Lim, MD Facility: Morgan Stanley Children's Hospital New York, United States Principal Investigator: Julie Khlvner, MD Facility: Stony Brook University Stony Brook, United States Principal Investigator: Rupinder Gill, MD Facility: Duke University Children's Hospital Durham, United States Principal Investigator: Leon Reinstein, MD Facility: Nationwide Children's Hospital Columbus, United States Principal Investigator: Carlo DiLorenzo, MD Facility: Children's Hospital of Philadelphia Philadelphia, United States Principal Investigator: Natalie Terry, MD Facility: Texas Children's Hospital Houston, United States Principal Investigator: Bruno Chumpatazi, MD Facility: Primary Children's Medical Center Salt Lake City, United States Principal Investigator: Molly O'Gorman, MD
Facility: Children's Hospital of Wisconsin Milwaukee, United States Principal Investigator: Adrian Miranda, MD
Information Source ID Number: S2002 NCT Identifier: NCT01914003 Health Authority: United States: Food and Drug Administration Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01914003 ClinicalTrials.gov processed this data on August 25, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the full source link above for retrieving further details from the government database.