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

This study has been completed.
Information provided by:
University Hospitals, Leicester Identifier:
First received: November 24, 2006
Last updated: February 13, 2009
Last verified: February 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 Intervention Phase
Lactose Intolerance Ulcerative Colitis Dietary Supplement: Lactose in water Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Symptoms of pain and diarrhoea [ Time Frame: Over 48 hours ]

Estimated Enrollment: 48
Study Start Date: April 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with known lactose intolerance Dietary Supplement: Lactose in water


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lactose intolerance

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00403923

United Kingdom
Leicester General Hospital
Leicester, Leicestershire, United Kingdom, LE5 4PW
Sponsors and Collaborators
University Hospitals, Leicester
Principal Investigator: John F Mayberry, DSc MD University Hospitals, Leicester
  More Information

Responsible Party: Carolyn Burden, University Hospitals of Leicester Identifier: NCT00403923     History of Changes
Other Study ID Numbers: UHL 10253
Study First Received: November 24, 2006
Last Updated: February 13, 2009

Keywords provided by University Hospitals, Leicester:
Lactose intolerance
Ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Lactose Intolerance
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Malabsorption Syndromes
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases processed this record on September 25, 2017