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Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings
Published on: February 7, 2025
An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind,
Jean-Christophe Rozé1, Sébastien Barbarot, Marie-José Butel
1Department of Neonatal Medicine, Nantes University Hospital, Boulevard Jean Monet, 44000 Nantes, France. jcroze@chu-nantes.fr
Insights
This study found that an experimental infant formula, enriched with alpha-lactalbumin and synbiotics, improved infant tolerance and reduced atopic dermatitis incidence. The formula demonstrated a protective effect against eczema development in non-breastfed neonates.
Area of Science:
- Pediatrics
- Immunology
- Microbiology
Background:
- Atopic dermatitis (AD) is a common inflammatory skin condition in infants.
- Infant nutrition plays a crucial role in immune system development and disease prevention.
- Early life gut microbiota composition is linked to AD development.
Purpose of the Study:
- To assess the safety, tolerance, and preventive effects of an experimental infant formula.
- The formula was enriched with alpha-lactalbumin and supplemented with synbiotics (probiotics and prebiotics).
- To evaluate the impact on infant growth, gastrointestinal tolerance, and atopic dermatitis manifestation.
Main Methods:
- A double-blind, multicentre, randomised controlled trial involving 97 non-breastfed term neonates.
- Infants received either the experimental formula (n=48) or standard formula (n=49) for 6 months.
- Outcomes included weight, gastrointestinal tolerance, atopic dermatitis incidence, and analysis of faecal secretory IgA (SIgA) and microbiota.
Main Results:
- Growth was comparable between the experimental and control groups.
- Infants on the experimental formula showed improved tolerance (less crying) at 1 month (P=0.03).
- A significantly lower incidence of atopic dermatitis was observed in the experimental group at 6 months (P<0.05).
- Decreased faecal SIgA correlated with AD and inversely with bifidobacteria colonization.
Conclusions:
- The experimental formula is safe and well-tolerated, supporting similar growth to standard formula.
- It offers a protective effect against the development of atopic dermatitis in infants.
- Synbiotic supplementation may modulate the gut immune response, influencing AD development.
Abstract:
The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P=0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P<0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P<0·014) and negatively correlated to the level of colonisation by bifidobacteria (P<0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.
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