Are we over-diagnosing lactose malabsorption and intolerance?
Research type
Research Study
Full title
Assessing the discrepancies between the results of a standard 25g lactose hydrogen breath tests (LHBT) and a more clinically relevant 12g LHBT’
IRAS ID
260345
Contact name
Imran Aziz
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 7 months, 10 days
Research summary
Lactose is a disaccharide present in dairy products. On consumption, lactose in hydrolysed by the enzyme lactase into glucose and galactose, which are subsequently absorbed into the small intestine. Failure to digest lactose leads to colonic fermentation and excess gas production, which is termed lactose malabsorption. This process of lactose malabsorption can be associated with the development of gastrointestinal symptoms, such as abdominal pain, nausea, bloating, and diarrhoea.
The lactose hydrogen breath test is a non-invasive test used to diagnose lactose malabsorption and intolerance. It involves the administration of a highly concentrated lactose drink followed by patients providing breath samples, and recording gastrointestinal symptoms, every 15-30 minutes over a period of up to 3 hours. Currently, standard protocol uses a lactose drink containing 50g lactose, which is the equivalent to 4 cups of milk. For many people this is a supra-physiological dose and is unlikely to be representative of lactose consumption in one sitting and may lead to over diagnosis. Moreover, this may lead to inappropriate dietician referrals and unnecessary dietary restrictions.
The aim of this study is to assess the discrepancy between the results of lactose hydrogen breath tests, when following the standard protocol using a ‘supra-physiological’ 50g dose of lactose, compared to the study protocol which will use a ‘physiological’ 12g dose of lactose.
This study will be performed by the department of Gastrointestinal Physiology at the Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust. All patients that are booked for a lactose hydrogen breath test will be given the patient information sheet and asked to self-complete a General Health Questionnaire booklet at home. We anticipate that completion of the GHQ will take 20-30 minutes. They will bring the GHQ when they attend for their standard 50g lactose hydrogen breath test.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0099
Date of REC Opinion
15 Mar 2019
REC opinion
Unfavourable Opinion