Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Researchers are studying a special baby formula designed for infants who have a higher chance of developing allergies. This formula contains 'partially hydrolyzed' ingredients, meaning some proteins are already partly broken down, making them easier to digest. It also has 'synbiotics', which are a mix of probiotics (good bacteria) and prebiotics (food for the good bacteria). The main goal is to find out if this special formula can help prevent eczema (atopic dermatitis), a common skin condition, from developing. Eczema is often one of the first signs of allergies in babies, sometimes called the 'allergic march'. The study will also look at how well babies tolerate the formula and if it's safe for them.
At a glance
What is this study about?
This study is exploring whether a specially designed baby formula can help protect newborns from developing eczema, a common skin condition that can be itchy and uncomfortable. Eczema, also known as atopic dermatitis, is often one of the first signs that a baby might develop other allergies like asthma or hay fever later on. Scientists sometimes call this progression the 'allergic march'.
The special formula being tested has two key features: it's 'partially hydrolyzed', which means the milk proteins in it are already partly broken down. This can make them easier for a baby's developing tummy to digest. It also contains 'synbiotics', which is a combination of friendly bacteria (probiotics) and the food that these good bacteria need to grow (prebiotics). These ingredients are thought to support a healthy gut, which in turn might help the immune system and the skin's natural barrier.
By helping to prevent eczema, the researchers hope to stop this 'allergic march' early on. The study will carefully compare babies who receive this special formula with those who receive a standard formula, or those who are breastfed. They will be checking how well the babies' skin is protected and if the formula is safe and well-tolerated. This research aims to give doctors and parents more options for helping babies at risk of allergies.
Key takeaways
- This study is about seeing if a special baby formula can help prevent eczema.
- It's for healthy newborn babies (under 14 days old) who have a family history of allergies.
- The formula contains partly broken-down proteins and a mix of good bacteria and their food (synbiotics).
- Participation involves either using the assigned formula or being part of the breastfed reference group.
- The goal is to stop the 'allergic march' early on in at-risk infants.
- Your baby's safety and well-being are a top priority throughout the study.
Who may be eligible?
This study is looking for healthy newborn babies who are less than 14 days old. They must have been born after at least 37 weeks of pregnancy and weigh between 2.5 kg and 4.5 kg at birth. Crucially, your baby needs to have a family history of allergies, meaning either you, your partner, or another child in your family has (or had) a medically diagnosed allergy.
Your baby can join if they are exclusively breastfed and you plan to continue breastfeeding for at least four months (these babies will be in a separate reference group). Or, your baby can join if they are mostly formula-fed, meaning formula makes up at least 75% of their daily milk intake, and you decided to start formula feeding before the study began. If you have twins or triplets, all siblings need to join together.
Babies cannot join if they have any serious health problems like infections, metabolic conditions, unconfirmed tummy issues, or if they've already been diagnosed with an allergy like eczema or a cow's milk allergy. Babies who need special medical formulas or have already been part of another medical study are also not eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my baby a newborn, no older than 14 days?
- Was my baby born after at least 37 weeks of pregnancy and weigh between 2.5kg and 4.5kg?
- Do I, my partner, or another child in our family have a medically diagnosed allergy?
- Is my baby generally healthy and not diagnosed with any allergies yet?
- If formula-fed, has formula been given for at least 75% of feeds, and did I decide on formula feeding before the study?
- If breastfed, am I exclusively breastfeeding and planning to continue for at least 4 months?
What does participation involve?
The detailed information about what taking part involves is not provided in this summary. However, typically, it would include regularly giving your baby the assigned formula or continuing breastfeeding, attending scheduled appointments or check-ups with the study team, and providing information about your baby's health and development over a period of time. There would likely be specific assessments to check your baby's skin and overall health. You would be informed about the total duration of your baby's participation during the informed consent process.
Potential risks and benefits
Locations (23)
- AZ Sint-Jan Brugge-Oostende AV - Campus Sint-JanVerified postcodeBruges, Belgium· Recruiting
- Universitair Ziekenhuis Brussel - KinderziekenhuisVerified postcodeBrussels, Belgium· Recruiting
- Clinique Ste ElisabethVerified postcodeNamur, Belgium· Recruiting
- CHU Amiens PicardieVerified postcodeAmiens, France· Recruiting
- CHU de CaenVerified postcodeCaen, France· Recruiting
- CHU de Grenoble AlpesVerified postcodeGrenoble, France· Recruiting
- Hôpital de la Croix RousseVerified postcodeLyon, France· Recruiting
- Hôpital Charles NicolleVerified postcodeRouen, France· Recruiting
- CHRU de ToursVerified postcodeTours, France· Recruiting
- Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)Verified postcodeBerlin, Germany· Not yet recruiting
- Evangelisches Krankenhaus Düsseldorf - FrauenklinikVerified postcodeDüsseldorf, Germany· Recruiting
- Klinik für Kinder- und Jugendmedizin, Universitätsklinikum FrankfurtVerified postcodeFrankfurt, Germany· Recruiting
Common questions
What is eczema?
Eczema, or atopic dermatitis, is a very common skin condition that makes the skin red, itchy, and sometimes dry or scaly. It often starts in babies and can be really uncomfortable for them.
What does 'partially hydrolyzed formula' mean?
It means the proteins in the milk have been partly broken down into smaller pieces. This makes them easier for a baby's tummy to digest, which might be helpful for babies at risk of allergies.
What are 'synbiotics'?
Synbiotics are a mix of two things: 'probiotics' (which are good bacteria that live in the gut) and 'prebiotics' (which are food for these good bacteria). They work together to support a healthy gut.
Why is family history of allergy important for this study?
Babies with a family history of allergies (like in a parent or sibling) are considered more likely to develop allergies themselves. This study is specifically looking at preventing allergies in this 'at-risk' group.
Can I still breastfeed my baby if they join the study?
Yes, there is a group in the study for exclusively breastfed babies, as long as you intend to continue breastfeeding for at least four months.
How to find out more
Amelie Goyer, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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