Lactose IntoleranceNCT00844766
Validation of a Home-screening Test for Lactose Intolerance
An observational study of Lactose Intolerance, run by University Hospitals, Leicester.
Trial summary
The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lactose Intolerance
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with lactose intolerance
Who may be able to join
- Diagnosed lactose intolerance as demonstrated by a lactose tolerance test
- Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test
Who cannot join
- Pregnant
- Breastfeeding
- Unwillingness to comply with study outline
About this study
Official title: A Study to Validate a Home-screening Test for Lactose Intolerant People
The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test.
This study will validate a simple home-screening test that uses lactose and not milk.
- Conditions
- Lactose Intolerance
- Keywords
- Lactose intolerance, Lactose, Home-screening test, Validate
- Medical subject headings
- Lactose Intolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startDec 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: This study was stopped as no patient asked to participate was prepared to do so
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Investigators
- John F Mayberry, DSc MD, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844766
- Sponsor's protocol ID
- UHL 10268
- Status last verified
- Apr 2019
- First submitted
- 13 Feb 2009
- Last updated
- 4 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Validate a Home-screening Test for Lactose Intolerant People
- ClinicalTrials.gov ID
- NCT00844766
- Acronym / sponsor ID
- UHL 10268
- Conditions
- Lactose Intolerance
- Keywords
- Lactose intolerance, Lactose, Home-screening test, Validate
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study was stopped as no patient asked to participate was prepared to do so
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Dec 2006 (actual)
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test.
This study will validate a simple home-screening test that uses lactose and not milk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with lactose intolerance
Key inclusion criteria (2 listed)
- Diagnosed lactose intolerance as demonstrated by a lactose tolerance test
- Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test
Key exclusion criteria (3 listed)
- Pregnant
- Breastfeeding
- Unwillingness to comply with study outline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Mayberry, DSc MD principal investigator
University Hospitals, Leicester
Questions about this trial
What is this clinical trial studying?
An observational study of Lactose Intolerance, run by University Hospitals, Leicester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.