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NCT00247806 Clinical Trial

Prevalence of Lactose Intolerance Following Stem Cell Transplantation

Lactose Intolerance Clinical Trial

Official title:
Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00247806
Other study ID # C05-0180
Secondary ID
Status Terminated
Phase Phase 1
First received October 31, 2005
Last updated September 24, 2008
Start date October 2008
Est. completion date December 2010

Study information
Verified date October 2005
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada BC Children's Hospital Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

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