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Amount of Lactose Causing Symptoms in Lactose Intolerant People

This study is not yet open for participant recruitment.
Verified by University Hospitals, Leicester, November 2006

Sponsored by: University Hospitals, Leicester
Information provided by: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00395954
  Purpose

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
Phase 0

MedlinePlus related topics:   Lactose Intolerance   

ChemIDplus related topics:   Lactose   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Longitudinal, Random Sample, Prospective Study
Official Title:   A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People.

Further study details as provided by University Hospitals, Leicester:

Estimated Enrollment:   48

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395954

Contacts
Contact: Lydia K Harrington     0116 2584786 ext 4786     lkh10@le.ac.uk    
Contact: John F Mayberry, DSc MD     0116 2584786 ext 4786     jmaybe@tiscali.co.uk    

Sponsors and Collaborators
University Hospitals, Leicester

Investigators
Principal Investigator:     John F Mayberry, DSc MD     University Hospitals, Leicester    
  More Information

Study ID Numbers:   UHL 10217
First Received:   November 2, 2006
Last Updated:   November 2, 2006
ClinicalTrials.gov Identifier:   NCT00395954
Health Authority:   United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:
Lactose Intolerance  
Lactose  
Threshold  

Study placed in the following topic categories:
Metabolism, Inborn Errors
Metabolic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Gastrointestinal Diseases
Malabsorption Syndromes
Metabolic disorder
Intestinal Diseases
Lactose Intolerance

Additional relevant MeSH terms:
Carbohydrate Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on September 04, 2008




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