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Amount of Lactose Causing Symptoms in Lactose Intolerant People

This study has been completed.
Information provided by:
University Hospitals, Leicester Identifier:
First received: November 2, 2006
Last updated: February 13, 2009
Last verified: February 2009

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)

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
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 identifier: 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 Identifier: NCT00395954     History of Changes
Other Study ID Numbers: UHL 10217
Study First Received: November 2, 2006
Last Updated: February 13, 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 processed this record on September 21, 2017