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Amount of Lactose Causing Symptoms in Lactose Intolerant People

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 6, 2006
Last Update Posted: February 16, 2009
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.
Information provided by:
University Hospitals, Leicester

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 Early Phase 1

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:

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
Principal Investigator: John F Mayberry, DSc MD University Hospitals, Leicester
  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 Submitted: November 2, 2006
First Posted: November 6, 2006
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University Hospitals, Leicester:
Lactose Intolerance

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