Validation of a Home-screening Test for Lactose Intolerance
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ClinicalTrials.gov Identifier: NCT00844766 |
Recruitment Status :
Withdrawn
(This study was stopped as no patient asked to participate was prepared to do so)
First Posted : February 16, 2009
Last Update Posted : April 4, 2019
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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 or disease |
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Lactose Intolerance |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Study to Validate a Home-screening Test for Lactose Intolerant People |
Actual Study Start Date : | December 2006 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | February 2007 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844766
Principal Investigator: | John F Mayberry, DSc MD | University Hospitals, Leicester |
Responsible Party: | Carolyn Burden, University Hospitals of Leicester NHS Trust |
ClinicalTrials.gov Identifier: | NCT00844766 |
Other Study ID Numbers: |
UHL 10268 |
First Posted: | February 16, 2009 Key Record Dates |
Last Update Posted: | April 4, 2019 |
Last Verified: | April 2019 |
Lactose intolerance Lactose Home-screening test Validate |
Lactose Intolerance Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |