Lactose IntoleranceNCT00395954
Amount of Lactose Causing Symptoms in Lactose Intolerant People
An observational study of Lactose Intolerance, run by University Hospitals, Leicester.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lactose Intolerance
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jun 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
Who may be able to join
- 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.
Who cannot join
- Failure to adhere to a lactose free diet.
- People who are on lactose containing medications.
- Pregnancy.
- Unwillingness to comply with study outline.
About this study
Official title: 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.
- Conditions
- Lactose Intolerance
- Keywords
- Lactose Intolerance, Lactose, Threshold
- 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 posted6 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
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
- NCT00395954
- Sponsor's protocol ID
- UHL 10217
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 2006
- Last updated
- 16 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People.
- ClinicalTrials.gov ID
- NCT00395954
- Acronym / sponsor ID
- UHL 10217
- Conditions
- Lactose Intolerance
- Keywords
- Lactose Intolerance, Lactose, Threshold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 6 Nov 2006 (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 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Failure to adhere to a lactose free diet.
- People who are on lactose containing medications.
- Pregnancy.
- 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
Related trials for Lactose Intolerance
Not yet recruiting
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
Cow Milk Protein Allergy, Cow Milk Intolerance
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
Enrolling by invitationObservational study
Lactose Intolerance and Intestinal Permability
Lactose Intolerance, Adult Type, Intestinal Permability
Not yet recruitingObservational study
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
Lactose Intolerance
RecruitingPhase 3
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome
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 4 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: finished, as of the sponsor's last update on 16 Feb 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 16 Feb 2009.