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Amount of Lactose Causing Symptoms in Lactose Intolerant People

This study has been completed.
Sponsor:
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00395954
First received: November 2, 2006
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  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

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:

U.S. FDA Resources

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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Carolyn Burden, University Hospitals of Leicester NHS Trust
ClinicalTrials.gov Identifier: NCT00395954     History of Changes
Other Study ID Numbers: UHL 10217
Study First Received: November 2, 2006
Last Updated: February 13, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Lactose Intolerance
Carbohydrate Metabolism, Inborn Errors
Digestive System Diseases
Gastrointestinal Diseases
Genetic Diseases, Inborn
 Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on February 27, 2015