Validation of a Home-Screening Test for Lactose Intolerance

This study has suspended participant recruitment.

(This study was stopped as no patient asked to participate was prepared to do so)

Sponsor:

Information provided by:

University Hospitals, Leicester

ClinicalTrials.gov Identifier:

NCT00844766

First received: February 13, 2009

Last updated: NA

Last verified: February 2009

History: No changes posted

Purpose

The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test.

This study will validate a simple home-screening test that uses lactose and not milk.

Condition	Phase
Lactose Intolerance	Phase 0


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Study to Validate a Home-Screening Test for Lactose Intolerant People

Resource links provided by NLM:

Genetics Home Reference related topics: lactose intolerance

MedlinePlus related topics: Lactose Intolerance

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:


Estimated Enrollment:	40
Study Start Date:	December 2006

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

People with lactose intolerance

Criteria

Inclusion Criteria:

Diagnosed lactose intolerance as demonstrated by a lactose tolerance test
Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test

Exclusion Criteria:

Pregnant
Breastfeeding
Unwillingness to comply with study outline

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844766

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:	NCT00844766 History of Changes
Other Study ID Numbers:	UHL 10268
Study First Received:	February 13, 2009
Last Updated:	February 13, 2009
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:


Lactose intolerance Lactose Home-screening test Validate

Additional relevant MeSH terms:


Lactose Intolerance Carbohydrate Metabolism, Inborn Errors Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn	Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on March 01, 2015

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