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Completed

NCT Number: NCT00403923

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Failure to adhere to a lactose free diet.
  • Pregnancy.
  • Unwillingness to comply with study outline.

Treatment and study plan

Lactose in water

Dietary Supplement

Primary outcomes

  1. Symptoms of pain and diarrhoea

    Time frame: Over 48 hours

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 27, 2006
Registry last updated
Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.