Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00403923|
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : February 16, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lactose Intolerance Ulcerative Colitis||Dietary Supplement: Lactose in water||Early Phase 1|
|Study Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis|
|Study Start Date :||April 2007|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
|Patients with known lactose intolerance||Dietary Supplement: Lactose in water|
- Symptoms of pain and diarrhoea [ Time Frame: Over 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403923
|Leicester General Hospital|
|Leicester, Leicestershire, United Kingdom, LE5 4PW|
|Principal Investigator:||John F Mayberry, DSc MD||University Hospitals, Leicester|