Prevalence of Lactose Intolerance Following Stem Cell Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

October 31, 2005

Last Updated Date

September 24, 2008

Start Date ^ICMJE

October 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00247806 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Prevalence of Lactose Intolerance Following Stem Cell Transplantation

Official Title ^ICMJE

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

Brief 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.

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 Phase

Phase I

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

Lactose Intolerance

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

4 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00247806

Responsible Party

Dr. Colin C Barker, University of British Columbia

Study ID Numbers ^ICMJE

C05-0180

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Colin Barker, PhD

University of British Columbia

Information Provided By

University of British Columbia

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP