Pancreatin in CMA Version 3.1 05/07/2021
Research type
Research Study
Full title
A feasibility study of pancreatin treatment on symptom resolution in exclusively breastfed infants with Cow’s Milk Allergy.
IRAS ID
292492
Contact name
Mich Lajeunesse
Contact email
Sponsor organisation
University Hospitals Southampton NHS Foundation Trust
Eudract number
2021-001913-36
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This is a feasibility study to demonstrate the Acceptability, Tolerability, and Adherence to the use of pancreatic enzymes for the treatment of CMA in both mother and infant, and to explore barriers to the recruitment on to this study.
Cow’s milk allergy affects 2.4% of babies in the UK. Symptoms may include vomiting, colic, constipation or diarrhoea, and eczema. Breastfed babies receive cow’s milk protein through breast milk from the mother’s diet so they can also get milk allergy. Treatment for a breastfed baby is the complete exclusion of dairy from the mother’s diet. Many babies will still have symptoms of milk allergy after the maternal exclusion so that mothers stop breastfeeding and often start expensive hypoallergenic formula bottles.
Our study aims to look at the effects of taking digestive enzyme supplements in breastfed babies with milk allergy. We expect them to digest out any remaining cow’s milk from the baby’s diet. It should allow mothers to breastfeed and not have to restrict dairy intake.
We plan to enroll 24 exclusively breastfed mother-infant pairs with CMA. It is a single-center study and will be conducted at University Hospital Southampton. After a maternal challenge with milk to confirm the diagnosis and baseline observation period they will commence oral pancreatin for 4 weeks with milk containing maternal diet.
We will randomize the order of supplementation to mother or infant and cross over after 4 weeks. We will use objective scores and maternal Quality Of Life scores as well as subjective symptom diaries to assess the response.We believe that breastfeeding is the best choice for mothers and babies and should be promoted wherever possible. We hope that our small study will give the data needed to fund a pilot study followed by a randomized controlled study and change treatment for breastfed babies with milk allergy.
REC name
Wales REC 5
REC reference
21/WA/0200
Date of REC Opinion
28 Jul 2021
REC opinion
Further Information Favourable Opinion