- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247806
Prevalence of Lactose Intolerance Following Stem Cell Transplantation
September 24, 2008 updated by: University of British Columbia
Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Colin Barker, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
October 31, 2005
First Submitted That Met QC Criteria
October 31, 2005
First Posted (Estimate)
November 2, 2005
Study Record Updates
Last Update Posted (Estimate)
September 25, 2008
Last Update Submitted That Met QC Criteria
September 24, 2008
Last Verified
October 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C05-0180
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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