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Prevalence of Lactose Intolerance Following Stem Cell Transplantation

This study has been terminated.
(Too few patients completed the study once enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247806
First Posted: November 2, 2005
Last Update Posted: September 25, 2008
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.
Information provided by:
University of British Columbia
  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 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247806


Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Colin Barker, PhD University of British Columbia
  More Information

Responsible Party: Dr. Colin C Barker, University of British Columbia
ClinicalTrials.gov Identifier: NCT00247806     History of Changes
Other Study ID Numbers: C05-0180
First Submitted: October 31, 2005
First Posted: November 2, 2005
Last Update Posted: September 25, 2008
Last Verified: October 2005

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

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases