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

Completed

• Conditions: Lactose Intolerance; Ulcerative Colitis
• Interventions: Dietary Supplement: Lactose in water

• Registration Number: NCT00403923
• Lead Sponsor: University Hospitals, Leicester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-24
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Study Start: 2007-04
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with known lactose intolerance	Lactose in water	-

Primary Outcome Measures

Name	Time	Method
Symptoms of pain and diarrhoea	Over 48 hours

Trial Locations

Locations (1)

Leicester General Hospital; 🇬🇧 Leicester, Leicestershire, United Kingdom