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
  Purpose

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
Phase 0

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with lactose intolerance

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403923

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

No publications provided

Responsible Party: Carolyn Burden, University Hospitals of Leicester
ClinicalTrials.gov Identifier: NCT00403923     History of Changes
Other Study ID Numbers: UHL 10253
Study First Received: November 24, 2006
Last Updated: February 13, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Lactose Intolerance
Ulcer
Colitis, Ulcerative
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Malabsorption Syndromes
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014