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Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00403923
First received: November 24, 2006
Last updated: February 13, 2009
Last verified: February 2009

November 24, 2006
February 13, 2009
April 2007
June 2007   (final data collection date for primary outcome measure)
Symptoms of pain and diarrhoea [ Time Frame: Over 48 hours ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00403923 on ClinicalTrials.gov Archive Site
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Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis
A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis

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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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

Patients with lactose intolerance

  • Lactose Intolerance
  • Ulcerative Colitis
Dietary Supplement: Lactose in water
Patients with known lactose intolerance
Intervention: Dietary Supplement: Lactose in water
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed lactose intolerance demonstrated with a lactose intolerance test.
  2. Confirmed ulcerative colitis demonstrated with histological and radiological tests.
  3. Adherence to a lactose free diet for at least four days before the start of the study.

Exclusion Criteria:

  1. Failure to adhere to a lactose free diet.
  2. Pregnancy.
  3. Unwillingness to comply with study outline.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00403923
UHL 10253
Yes
Carolyn Burden, University Hospitals of Leicester
University Hospitals, Leicester
Not Provided
Principal Investigator: John F Mayberry, DSc MD University Hospitals, Leicester
University Hospitals, Leicester
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP