Amount of Lactose Causing Symptoms in Lactose Intolerant People

This study has been completed.

First Received on November 2, 2006. Last Updated on February 13, 2009 History of Changes

Sponsor:	University Hospitals, Leicester
Information provided by:	University Hospitals, Leicester
ClinicalTrials.gov Identifier:	NCT00395954

Purpose

The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs.

This study will identify the threshold at which symptoms of lactose intolerance develop, to provide appropriate advice and treatment in the management of patients.

Condition	Phase
Lactose Intolerance	Phase 0

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People.

Resource links provided by NLM:

Genetics Home Reference related topics: lactose intolerance

MedlinePlus related topics: Lactose Intolerance

Drug Information available for: Lactose

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Estimated Enrollment:	48
Study Start Date:	November 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed lactose intolerance demonstrated with a lactose intolerance test.
Adherence to a lactose free diet for at least four days before the start of the study.

Exclusion Criteria:

Failure to adhere to a lactose free diet.
People who are on lactose containing medications.
Pregnancy.
Unwillingness to comply with study outline.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395954

Sponsors and Collaborators

University Hospitals, Leicester

Investigators

Principal Investigator:

John F Mayberry, DSc MD

University Hospitals, Leicester

More Information

No publications provided

Responsible Party:	Carolyn Burden, University Hospitals of Leicester NHS Trust
ClinicalTrials.gov Identifier:	NCT00395954 History of Changes
Other Study ID Numbers:	UHL 10217
Study First Received:	November 2, 2006
Last Updated:	February 13, 2009
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:

Lactose Intolerance
Lactose
Threshold

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

ClinicalTrials.gov processed this record on February 12, 2012