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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00403923
Enrollment
48
Registered
2006-11-27
Start date
2007-04-30
Completion date
2007-06-30
Last updated
2009-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose Intolerance, Ulcerative Colitis

Keywords

Lactose intolerance, Ulcerative colitis, Lactose, Threshold

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.

Interventions

DIETARY_SUPPLEMENTLactose in water

Sponsors

University Hospitals, Leicester
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Symptoms of pain and diarrhoeaOver 48 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026