The results of a new study on probiotics and oral immunotherapy (OIT) for peanut allergy from the Murdoch Childrens Research Institute in Australia recently generated international headlines after 80 percent of children enrolled in the study were able to tolerate peanut at the end of the trial. This study was partially funded by the Food Allergy & Anaphylaxis Network, one of FARE’s legacy organizations. Researchers sought to determine whether probiotics combined with oral immunotherapy could lead to “sustained unresponsiveness,” which the authors describe as the ability to tolerate a food after discontinuation of OIT.
In this clinical trial conducted during a period of 18 months, 62 children with peanut allergy were either given a placebo or a dose of a probiotic together with peanut protein in increasing amounts. Six participants withdrew from the study (three from each group). The study reports that possible sustained unresponsiveness – assessed 2-5 weeks after discontinuation of the treatment — was achieved in 23 out of the 28 participants (82 percent) who were given the probiotic and underwent OIT.
Researchers reported that the proportion of children (45 percent) who experienced reactions during the treatment was in line with other reports from OIT studies. The authors also noted that future trials that would compare the results of the probiotic alone, allergen OIT alone, combined probiotic/allergen OIT and placebo are required (a) to clarify whether probiotic or OIT alone can provide similar benefits or “whether combined therapy yields synergistic benefits” and (b) to further investigate the underlying immune mechanisms. Further work is also required to confirm whether patients can still tolerate peanut for longer than 6 weeks after finishing the study.
While we are pleased that the investigators were able to publish this work in the prestigious Journal of Allergy and Clinical Immunology, FARE’s CEO, Dr. James R. Baker, Jr. cautions, “the implications of this early study are not at all clear. In particular, it is not apparent that the probiotics played any role in this trial as it is already known that OIT can have significant positive therapeutic effects.” Also important to note, almost a fifth of patients in the active treatment group were not “desensitized,” and one patient had severe allergic reactions to the therapy and was forced to discontinue the trial. “This demonstrates that even this ‘combined’ probiotic and OIT therapy was not safe in all patients, and should not be attempted at home by families managing food allergies,” Baker added. While the authors identified these cautions in their article, most were not communicated in the widespread media coverage.
There is no FDA-approved treatment for food allergy, and these experimental treatment approaches should not be tried at home. For information on food allergy research, please visit www.foodallergy.org/research.