Adding a Probiotic to Peanut Oral Immunotherapy in Children

Taking probiotics linked to weight loss.
Taking probiotics linked to weight loss.
A clinical trial of peanut oral immunotherapy in 1-10 year olds assessed the efficacy of OIT and whether adding a probiotic to OIT reduced gastrointestinal adverse events.

For children with peanut allergy, the addition of a probiotic to peanut oral immunotherapy (OIT) may improve safety and tolerability of OIT, according to a study published in The Lancet Child & Adolescent Health.

While peanut OIT has been shown to be effective at inducing desensitization to allergens, it has also been associated with treatment-related reactions. The addition of immune response modifiers (probiotics or Toll-like receptor agonists) has been suggested to improve the effectiveness or safety of OIT.

Researchers investigated whether addition of a probiotic adjuvant improved the efficacy or safety of peanut OIT in children aged 1 to10 years in a phase 2b trial conducted in 3 hospitals in Australia. A total of 201 participants were randomly assigned to receive probiotic and peanut oral immunotherapy (PPOIT group; n = 79), placebo probiotic and peanut OIT (OIT group; n = 83), or placebo probiotic and placebo OIT (placebo group; n = 39) for 18 months.

The researchers found that 36 (46%) of 79 children in the PPOIT group and 42 (51%) of 83 children in the OIT group achieved sustained unresponsiveness compared with 2 (5%) of 39 children in the placebo group (P<.0001), with no significant difference between PPOIT and OIT (P=.52). In addition, treatment-related adverse events were reported in 72 (91%) of 79 children in the PPOIT group, 73 (88%) of 83 children in the OIT group, and 28 (72%) of 39 children in the placebo group. Twelve months post-treatment, 60 (85%) of 71 participants in the PPOIT group, 60 (86%) of 70 participants in the OIT group, and 6 (18%) of 34 participants in the placebo group were eating peanut, with rescue epinephrine being used infrequently. Researchers also found that children aged 1-5 years had higher rates of sustained unresponsiveness to peanut allergens.

“Both PPOIT and OIT were effective at inducing sustained unresponsiveness,” the  researchers concluded.  “Addition of probiotic did not improve efficacy of OIT but might provide a meaningful safety benefit, particularly for children aged 1–5 years, by reducing the burden of gastrointestinal symptoms and systemic reactions,” they added.

Disclosure: This research was supported by National Health and Medical Research Council Australia and Prota Therapeutics. Please see the original reference for a full list of disclosures.


Loke P, Orsini F, Lozinsky AC, et al; PPOIT-003 study group. Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial. Lancet Child Adolesc Health. Published online February 3, 2022. doi:10.1016/S2352-4642(22)00006-2