Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG reduces the occurrence of other allergic manifestations in children with cow's milk allergy: 3‐year randomized controlled trial
- 2017-06
- Journal of Allergy and Clinical Immunology 139(6)
- PubMed: 28043872
- DOI: 10.1016/j.jaci.2016.10.050
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 220
- Population
- Children with IgE-mediated cow's milk allergy
- Methods
- Randomized Controlled Trial
- Highly Cited
Abstract
Background: Children with cow's milk allergy (CMA) have an increased risk of other allergic manifestations (AMs).
Objective: We performed a parallel-arm randomized controlled trial to test whether administration of an extensively hydrolyzed casein formula (EHCF) containing the probiotic Lactobacillus rhamnosus GG (LGG) can reduce the occurrence of other AMs in children with CMA.
Methods: Children with IgE-mediated CMA were randomly allocated to the EHCF or EHCF+LGG groups and followed for 36 months. The main outcome was occurrence of at least 1 AM (eczema, urticaria, asthma, and rhinoconjunctivitis). The secondary outcome was tolerance acquisition, which was defined as the negativization of a double-blind food challenge results at 12, 24, and 36 months. AMs were diagnosed according to standardized criteria. Tolerance acquisition was evaluated every 12 months.
Results: A total of 220 children (147 boys [67%]) with a median age of 5.0 months (interquartile range, 3.0-8.0 months) were randomized; 110 children were placed in the EHCF group, and 110 children were placed in the EHCF+LGG group. In the complete case analysis the absolute risk difference for the occurrence of at least 1 AM over 36 months was -0.23 (95% CI, -0.36 to -0.10; P < .001), and the absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P < .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P < .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P < .001) at 36 months. In the sensitivity analysis the effect size of the main outcome was virtually unchanged when the occurrence of AMs was assigned to all 27 missing children.
Conclusions: EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA.
Keywords: Eczema; asthma; atopic march; food allergy; gut microbiota; probiotics; rhinoconjunctivitis; urticaria.
Research Insights
| Supplement | Dose | Health Outcome | Effect Type | Effect Size | Source |
|---|---|---|---|---|---|
| Lactobacillus rhamnosus DSM33560 | — | Improved Cow's Milk Tolerance | Beneficial | Moderate | View sourcethe absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P < .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P < .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P < .001) at 36 months |
| Lactobacillus rhamnosus DSM33560 | — | Reduced Incidence of Allergic Manifestations | Beneficial | Large | View sourceEHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA. |
| Lactobacillus rhamnosus LCS-742 | — | Accelerated Oral Tolerance Development | Beneficial | Large | View sourceEHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA. |
| Lactobacillus rhamnosus LCS-742 | — | Reduced Incidence of Allergic Manifestations | Beneficial | Large | View sourceEHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA. |
| Lactobacillus rhamnosus MAK79L08R | — | Improved Oral Tolerance | Beneficial | Large | View sourceThe absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P < .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P < .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P < .001) at 36 months. |
| Lactobacillus rhamnosus MAK79L08R | — | Reduced Incidence of Allergic Manifestations | Beneficial | Large | View sourceEHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA. |
| Lactobacillus rhamnosus R0343ND | — | Reduced Incidence of Allergic Manifestations | Beneficial | Large | View sourceEHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA. |
| Lactobacillus rhamnosus VPro 11 | — | Improved Cow's Milk Tolerance | Beneficial | Moderate | View sourcethe absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P < .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P < .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P < .001) at 36 months |