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Prevalence of Lactose Intolerance Following Stem Cell Transplantation.

This study is not yet open for participant recruitment.
Verified by University of British Columbia, October 2005

Sponsored by: University of British Columbia
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00247806
  Purpose

It is currently assumed that all patients are lactose intolerant post bone marrow transplantation. This pilot study is to assess what the incidence of lactose intolerance is after bone marrow transplantation in children. This will be done using a lactose breath test.


Condition Phase
Lactose Intolerance
Phase I

MedlinePlus related topics:   Lactose Intolerance   

ChemIDplus related topics:   Lactose   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:   Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.

Further study details as provided by University of British Columbia:

Estimated Enrollment:   20
Study Start Date:   October 2005
Estimated Study Completion Date:   October 2006

Detailed Description:

All pediatric patients over the age of 4 years who are scheduled for a stem cell transplant will be approached to assess whether what the incidence of lactose intolerance is in the post transplant period and how quickly recovery occurs. A baseline lactose and lactulose breath test will be performed followed by repeat lactose breath tests starting 2 weeks after day 0 and repeated every fortnight for 10 weeks. Stool pH and reducing substances will be checked at the time of the breath tests to see if there is any correlation.

  Eligibility
Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

All patients planned to undergo a stem cell transplant.

Exclusion Criteria:

refusal to participate, Unable to perform breath tests on request (generally under the age of 4 years.).

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247806

Contacts
Contact: Colin C Barker     cbarker@cw.bc.ca    

Locations
Canada, British Columbia
BC Children’s Hospital     Not yet recruiting
      Vancouver, British Columbia, Canada, V6H 3V4
      Contact: Colin C Barker, PhD         cbarker@cw.bc.ca    
      Principal Investigator: Colin C Barker, PhD            

Sponsors and Collaborators
University of British Columbia

Investigators
Principal Investigator:     Colin Barker, PhD     University of British Columbia    
  More Information

Study ID Numbers:   C05-0180
First Received:   October 31, 2005
Last Updated:   October 31, 2005
ClinicalTrials.gov Identifier:   NCT00247806
Health Authority:   Canada: Health Canada

Keywords provided by University of British Columbia:
Pilot, pediatric, stem cell transplant, lactose intolerance  

Study placed in the following topic categories:
Metabolism, Inborn Errors
Metabolic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Gastrointestinal Diseases
Malabsorption Syndromes
Metabolic disorder
Intestinal Diseases
Lactose Intolerance

Additional relevant MeSH terms:
Carbohydrate Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on September 04, 2008




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