Lactobacillus rhamnosus HN001 - Baby & Infant Clinical Studies

In the realm of nurturing the health and well-being of babies and infants during their crucial early years, the exploration of innovative solutions takes centre stage. As we delve into the realm of probiotics and their potential impact on early childhood development, the question arises: Could L. rhamnosus HN001™ prove to be an asset in promoting the health and resilience of our youngest generation? In this article, we embark on a journey to uncover the science, potential benefits, and considerations surrounding the integration of L.rhamnosus HN001™ in the delicate stages of infancy and early childhood.

Overview:

Significant and robust long-term clinical evidence has been established through a unique extended study focusing on childhood eczema across durations of 2, 4, 6, and 11 years.

After a 2-year follow-up, a double-blind, randomised, placebo-controlled trial revealed distinct effects of two probiotics in preventing eczema and atopy.

At the 4-year follow-up, the protective impact of Lactobacillus rhamnosus HN001 against eczema during the initial 2 years of life remained evident up to 4 years of age.

Upon the 6-year follow-up, early supplementation with Lactobacillus rhamnosus HN001 exhibited a reduction in eczema prevalence up to 6 years, raising the question of whether it also reduces atopic sensitisation.

The 11-year follow-up demonstrated the influence of Lactobacillus rhamnosus HN001 in early life on the cumulative prevalence of allergic disease up to 11 years.

Study Objective:

The study aimed to investigate whether the daily consumption of L. rhamnosus HN001™ and Bifidobacterium animalis ssp. lactis HN019™* could mitigate the occurrence and severity of eczema in children.

Research Design:

The study employed a randomized, placebo-controlled design across two centres.

Methodology:

Around 150 infants and children with a family history of allergies were randomly assigned to two treatment groups: placebo and HN001™ at a dose of 6 billion CFU per day. Pregnant mothers received treatment from approximately 5 weeks before term until 6 months post-term for breastfeeding mothers. Infants were administered the treatment from birth to 24 months old, with the supplements given alongside infant feeds such as breast milk, infant formula, and weaning food. Eczema prevalence and severity were assessed using the modified UK Working Party’s Diagnostic Criteria for atopic dermatitis in infants and the SCORing Atopic Dermatitis (SCORAD) with a cut off of ≥10 to distinguish from simple rashes. Health assessments occurred at 2, 4, 6, and 11 years.

Research Findings:

The administration of HN001™ was linked to a notable reduction in cumulative eczema prevalence, with a reduction of 49% at 2 years compared to placebo (P=0.01), sustaining a 42% lower cumulative prevalence over 11 years (P= 0.002). Additional analysis of 12-month data revealed a 61% decrease in eczema prevalence compared to placebo. A separate study focusing solely on supplementing mothers with HN001™ from 14 to 16 weeks of gestation through 6 months postpartum for breastfeeding did not exhibit risk reduction in eczema, emphasizing the need for supplementation in both mother and baby.

HN001™ was also associated with a significant reduction in cumulative eczema prevalence with SCORAD ≥10 over 6 years, showcasing a 43% decrease at 2 years compared to placebo (P=0.009), and maintaining a 31% lower cumulative prevalence over 6 years (P= 0.04). SCORAD assessments were not conducted at 11 years. Further analysis of 12-month data pointed to a 39% risk reduction in eczema prevalence with SCORAD ≥10 compared to placebo (P=0.06). A similar study limited to maternal supplementation did not display SCORAD risk reduction, further underscoring the necessity for supplementation in both mother and baby.

Moreover, the inclusion of HN001™ was linked to a substantial decrease in the prevalence of allergic sensitisation at 6 and 11 years. Skin prick tests were employed to measure immune reactions to allergens, revealing children in the HN001™ group to possess a significantly lower cumulative prevalence of allergic sensitization in comparison to those on placebo at 6 and 11 years (P=0.04 and P=0.048).

• Original study conducted by HOWRU
• Wickens K, Black P, Stanley TV, et al. A differential effect of 2 probiotics in the prevention of eczema and atopy: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2008;122(4):788-794
• Wickens K, Black P, Stanley TV, et al. A protective effect of Lactobacillus rhamnosus HN001 against eczema in the first 2 years of life persists to age 4 years. Clin Exp Allergy. 2012;42(7):1071-1079.
• Wickens K, Stanley TV, Mitchell EA, et al. Early supplementation with Lactobacillus rhamnosus HN001 reduces eczema prevalence to 6 years: does it also reduce atopic sensitization? Clin Exp Allergy. 2013;43(9):1048-57.
• Wickens K, Barthow C, Mitchell EA, et al. Effects of Lactobacillus rhamnosus HN001 in early life on the cumulative prevalence of allergic disease to 11 years. Pediatr Allergy Immunol. 2018 Dec;29(8):808-814. doi: 10.1111/pai.12982.
• Wickens K, Barthow C, Mitchell EA, et al. Maternal supplementation alone with Lactobacillus rhamnosus HN001 during pregnancy and breastfeeding does not reduce infant eczema. Pediatr Allergy Immunol. 2018;29(3);296-302. doi: 10.1111/pai.12874.