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
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.
Summary of Results
Exploring a New Way to Manage Cow’s Milk Allergy in Breastfed Babies
Why We Did This Study
Cow’s Milk Allergy (CMA) affects around 2.4% of babies in the UK. In breastfed babies, tiny amounts of cow’s milk protein from the mother’s diet can pass into breast milk and cause symptoms like:
* Tummy troubles
* Skin rashes
* Breathing issues
The usual treatment is for mothers to cut out all dairy, which can be hard to follow and may lead to early stopping of breastfeeding.
This study explored a new idea: using digestive enzymes (pancreatin) to help break down cow’s milk protein, possibly allowing mothers to continue eating dairy while breastfeeding.What the Study Involved
This was a feasibility study at University Hospital Southampton. We wanted to see if:
* Families were happy to take part
* The treatment was safe and manageable
* We could collect useful data
Who could take part?
* Babies under 12 months, born full-term
* Diagnosed with non-IgE mediated CMA
* Exclusively breastfed
What happened during the study?
1. Dairy reintroduction: Mothers ate dairy for 3 days to see if symptoms returned.
2. If symptoms worsened, babies were enrolled.
3. Over 8 weeks, families followed a cross-over plan:
* 4 weeks: either mum took enzyme capsules or baby received enzyme powder
* 4 weeks: they switched roles
4. We monitored baby’s symptoms, growth, and skin. Mums completed wellbeing questionnaires.What We Found
* 60 children were screened from allergy and dietitian clinics.
* 12 were eligible and interested.
* 7 did not show strong symptoms after dairy reintroduction — likely growing out of CMA.
* 2 withdrew (1 preterm, 1 lost to follow-up).
* 3 babies were enrolled.
* 1 withdrew for unrelated reasons
* 2 completed the study and received digestive enzymes Key observations:
* Both mothers continued breastfeeding while taking enzymes
* Both babies improved and tolerated cow’s milk in mum’s diet
* Mothers preferred taking capsules themselves over giving powder to babies
* Both chose to continue enzyme capsules after the study
* One mum said: “It has been a real success and has made a massive difference.”What Happens Next
* Recruitment was challenging — we plan to offer the study earlier, directly to families in primary care
* A new parent questionnaire worked well and will be used in future studies
* We aim to secure funding for a larger formal trial of digestive enzymes for CMA in breastfed babiesREC name
Wales REC 5
REC reference
21/WA/0200
Date of REC Opinion
28 Jul 2021
REC opinion
Further Information Favourable Opinion