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Sponsored by: |
University Hospitals, Leicester |
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Information provided by: | University Hospitals, Leicester |
ClinicalTrials.gov Identifier: | NCT00403923 |
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.
Study Type: | Observational |
Study Design: | Longitudinal, Random Sample, Prospective Study |
Official Title: | A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lydia K Harrington | 0116 258 4786 ext 4786 | lkh10@le.ac.uk |
Contact: John F Mayberry, DSc MD | 0116 258 4786 ext 4786 | jmaybe@tiscali.co.uk |
Principal Investigator: | John F Mayberry, DSc MD | University Hospitals, Leicester |
Study ID Numbers: | UHL 10253 |
Study First Received: | November 24, 2006 |
Last Updated: | November 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00403923 |
Health Authority: | United Kingdom: Research Ethics Committee |
Lactose intolerance Ulcerative colitis Lactose Threshold |
Metabolic Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Metabolism, Inborn Errors |
Digestive System Diseases Genetic Diseases, Inborn Malabsorption Syndromes Metabolic disorder Lactose Intolerance Gastroenteritis Colitis |
Pathologic Processes Carbohydrate Metabolism, Inborn Errors |