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CompletedNCT00403923Updated Feb 16, 2009

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

An observational study in Lactose Intolerance and Ulcerative Colitis, sponsored by University Hospitals, Leicester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-16.

Sponsored by University Hospitals, Leicester · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lactose Intolerance
  • Ulcerative Colitis

Keywords

  • Lactose intolerance
  • Ulcerative colitis
  • Lactose
  • Threshold
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 48 is below the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

University Hospitals, Leicester is the lead sponsor of 67 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with lactose intolerance

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

Exclusion Criteria:

  1. Failure to adhere to a lactose free diet.
  2. Pregnancy.
  3. Unwillingness to comply with study outline.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
48 participants (estimated)

Groups and cohorts

  • Patients with known lactose intolerance

    Dietary Supplement: Lactose in water

Interventions

  • Dietary supplementLactose in water
06

What researchers measure

Primary outcomes

  1. Symptoms of pain and diarrhoea

    Time frame: Over 48 hours

07

Study locations

1 site
  • Leicester General Hospital
    Leicester, Leicestershire LE5 4PW, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00403923
Lead sponsor
University Hospitals, Leicester
First posted
Nov 27, 2006
Start date
Apr 2007
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Feb 16, 2009

Study contacts

John F Mayberry, DSc MD
principal investigator · University Hospitals, Leicester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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