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

Sponsor

University Hospitals, Leicester (Other)

Overall Status

Completed

CT.gov ID

NCT00403923

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lactose Intolerance Ulcerative Colitis	Dietary Supplement: Lactose in water

Study Design

Study Type:

Observational

Anticipated Enrollment :

48 participants

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Patients with known lactose intolerance	Dietary Supplement: Lactose in water

Arm

Intervention/Treatment

Patients with known lactose intolerance

Dietary Supplement: Lactose in water

Outcome Measures

Primary Outcome Measures

Symptoms of pain and diarrhoea [Over 48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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