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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 24, 2006 | ||||
| Last Updated Date | February 13, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Symptoms of pain and diarrhoea [ Time Frame: Over 48 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00403923 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis | ||||
| Official Title ICMJE | A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis | ||||
| Brief Summary | The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis 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. There is disagreement amongst researchers regarding the amount of lactose needed to cause symptoms in those who are lactose intolerance. The general consensus is that the amount of lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who are lactose intolerant (1). However, there have been a number of studies and case studies that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little as 0.02 grams (6). Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum, characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence of lactose intolerance in patients with ulcerative colitis is not greater than in the general population, but there is no evidence as to whether these patients are more sensitive to lactose. This study will identify the threshold at which symptoms of lactose intolerance develop in those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice and treatment in the management of patients with these conditions. |
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| Detailed Description | |||||
| Study Phase | Phase 0 | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Crossover, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: Lactose in water | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00403923 | ||||
| Responsible Party | Carolyn Burden, University Hospitals of Leicester | ||||
| Study ID Numbers ICMJE | UHL 10253 | ||||
| Study Sponsor ICMJE | University Hospitals, Leicester | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University Hospitals, Leicester | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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