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Amount of Lactose Causing Symptoms in Lactose Intolerant People

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ClinicalTrials.gov Identifier: NCT00395954
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : February 16, 2009
Sponsor:
Information provided by:
University Hospitals, Leicester

Study Description
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Brief Summary:

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
Lactose Intolerance

Study Design
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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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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Principal Investigator: John F Mayberry, DSc MD University Hospitals, Leicester
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Carolyn Burden, University Hospitals of Leicester NHS Trust
ClinicalTrials.gov Identifier: NCT00395954     History of Changes
Other Study ID Numbers: UHL 10217
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

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