First milk in paediatric Crohn’s disease
Research type
Research Study
Full title
Dietary therapy to improve nutrition and gut health in paediatric Crohn’s disease; a feasibility study
IRAS ID
246070
Contact name
Stephen Allen
Contact email
Sponsor organisation
Alder Hey Children’s NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
Crohn’s disease (CD), an incurable, chronic inflammatory bowel disease, results in poor quality of life, adverse health outcomes and high treatment costs. Symptoms include abdominal pain, diarrhoea and poor growth. Exclusive enteral nutrition (EEN) for 6-8 weeks, where a milk feed is the sole source of nutrition, is recommended first-line treatment. Over 85% of children with active CD achieve clinical remission or improve during EEN. The problem is that disease flares occur with re-introduction of their usual diet. Continuing some of a special milk every day may help to maintain gut health and nutrition and reduce the risk of relapse. However, many children dislike the special milks and are not able to continue to take them long-term. We need dietary therapy that is effective but also acceptable for longer-term use. A novel dietary intervention which may be acceptable for long-term use is bovine colostrum (BC). BC is the first milk produced by cows after parturition and contains high levels of naturally occurring antimicrobial, immune-modulatory and growth-stimulating factors that reduce intestinal inflammation and improve mucosal integrity. Only a small amount of BC may be needed every day, it is tasteless and many different flavourings can be used to make a milkshake. In this randomized feasibility study, we aim to assess whether 50 children aged 8-18 years with stable CD of mild/moderate severity can take a daily supplement of BC alongside their normal diet over 6-12 weeks and whether this may improve gut health and nutrition. We will measure biomarkers of gut health and nutrition in blood and stool samples and do oral sugar absorption tests. We will also undertake qualitative research in a sub-set of 20 children/families to assess their perceptions of dietary therapy, BC and our research methods as a basis for designing a larger clinical trial.
Summary of Results
Nutritional supplements are effective both in the initial treatment of Crohn’s disease and its longer-term management. However, many younger people dislike the current products making longer-term use difficult. Bovine colostrum (“First milk”; FM), produced by cows for their newborn calves, may be more effective than manufactured milks as it contains natural factors that reduce inflammation and infection and help the intestine to heal. In this initial study, we aimed to see whether FM was acceptable to younger people taken daily for up to 3 months alongside their usual diet and to generate some initial information on its effects.
We only included younger people in whom Crohn’s disease was stable and either in remission or of mild/moderate severity and who were not already well settled on a nutritional supplement. These inclusion criteria turned-out to be rather restrictive, so that, although we screened a lot of our patients, we only recruited 23 out of our initial target of 50 children.
Children were allocated by chance to receive either FM or a placebo milk for weeks 1-6 (“blinded” phase) and then all received FM for weeks 7-12 (“open” phase). In total, 13/21 (61.9%) tolerated FM and the study procedures over 6 weeks and 7/12 (58.3%) over 3 months.
Through regular interviews and questionnaires, we found that most younger people found the FM acceptable to take. Opinions were mixed as to whether they preferred FM to placebo or other nutritional supplements. In this small study, clinical and laboratory variables were similar in younger people on FM and those on the placebo milk. FM did not result in any significant adverse effects.
Our findings indicate that FM is an acceptable nutritional supplement for longer-term use. Given its potential to improve gut health in Crohn’s disease, a clinical trial assessing its efficacy is appropriate.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0637
Date of REC Opinion
4 Oct 2018
REC opinion
Favourable Opinion