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

Ulcerative Colitis Clinical Trial

Official title:

A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403923
• Other study ID #: UHL 10253
• Status: Completed
• Phase: Phase 0
• First received: November 24, 2006
• Last updated: February 13, 2009
• Start date: April 2007
• Est. completion date: June 2007

Study information

• Verified date: February 2009
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Lactose Intolerance
• Ulcer
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Lactose in water

Locations

Country	Name	City	State
United Kingdom	Leicester General Hospital	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of pain and diarrhoea		Over 48 hours	No