Prevalence of Lactose Intolerance Following Stem Cell Transplantation

This study has been terminated.

( Too few patients completed the study once enrolled. )

First Received: October 31, 2005 Last Updated: September 24, 2008 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Lactose Intolerance

Drug Information available for: Lactose

U.S. FDA Resources

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

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

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

No publications provided

Responsible Party:	University of British Columbia ( Dr. Colin C Barker )
Study ID Numbers:	C05-0180
Study First Received:	October 31, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00247806 History of Changes
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
Intestinal Diseases
Lactose Intolerance
Metabolic Disorder

Additional relevant MeSH terms:

Metabolism, Inborn Errors
Metabolic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Gastrointestinal Diseases

Malabsorption Syndromes
Intestinal Diseases
Lactose Intolerance
Carbohydrate Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on September 10, 2009