Amount of Lactose Causing Symptoms in Lactose Intolerant People
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00395954 |
Recruitment Status :
Completed
First Posted : November 6, 2006
Last Update Posted : February 16, 2009
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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 or disease |
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Lactose Intolerance |
Study Type : | Observational |
Estimated Enrollment : | 48 participants |
Time Perspective: | Prospective |
Official Title: | A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People. |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 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 |
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.

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): NCT00395954
Principal Investigator: | John F Mayberry, DSc MD | University Hospitals, Leicester |
Responsible Party: | Carolyn Burden, University Hospitals of Leicester NHS Trust |
ClinicalTrials.gov Identifier: | NCT00395954 |
Other Study ID Numbers: |
UHL 10217 |
First Posted: | November 6, 2006 Key Record Dates |
Last Update Posted: | February 16, 2009 |
Last Verified: | February 2009 |
Lactose Intolerance Lactose Threshold |
Lactose Intolerance Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |