Amount of Lactose Causing Symptoms in Lactose Intolerant People

February 13, 2009 updated by: University Hospitals, Leicester

A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 2, 2006

First Posted (Estimate)

November 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHL 10217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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