Fecal Microbiome Transplant Shows Promise as Novel Treatment for Peanut Allergy in First-in-Human Trial
核心洞察
A Phase 1 trial found that six of 15 participants with peanut allergy (搜索) achieved improved tolerance after receiving fecal microbiome transplant (搜索) capsules, with effects lasting up to four months.
Before treatment, participants could not tolerate more than 100 mg of peanut protein; afterward, five could consume 600 mg or more—equivalent to about two and a half peanuts.
Experts highlight the sustained benefit as particularly exciting, contrasting it with current therapies whose effects wane without continued treatment and exposure.
A first-of-its-kind clinical trial has demonstrated that fecal microbiome transplantation (FMT) using stool capsules can improve tolerance to peanut exposure in adults with peanut allergy (搜索), marking the first evidence in humans that gut bacteria transfer can treat food allergy.
The Phase 1 trial results, published August 5 in Science Translational Medicine, showed that six of 15 participants with peanut allergy (搜索) achieved clinically meaningful improvements in their ability to tolerate peanut protein up to four months after receiving FMT capsules derived from healthy, non-allergic donors.
"We, as the food allergy community, have been waiting for these results," said Stephen Tilles, an allergist-immunologist and clinical professor at the University of Washington, who was not involved in the study. Tilles described the findings as "very exciting," while cautioning that the approach may not be "ready for prime time" yet.
Durable Tolerance Without Ongoing Treatment
Before enrollment, none of the participants could consume more than 100 milligrams of peanut protein—less than half a peanut—without developing an immune reaction. Four months after the transplant, one participant could tolerate 300 milligrams, and five could consume 600 milligrams or more, roughly equivalent to two and a half peanuts.
The durability of the response is what sets this approach apart, according to clinicians. "The potential of this type of therapy to have a lasting benefit is really, really exciting," said Edwin Kim, an allergist at the University of North Carolina at Chapel Hill. "That's been a struggle that we've had with the current other therapies. The benefit wanes and requires continued treatment, continued exposure, to maintain."
Current treatment options for food allergies remain limited. The standard of care consists of strict allergen avoidance and carrying an adrenaline auto-injector for emergency use following accidental exposure.
Trial Design and Key Observations
In the trial, researchers administered odorless and tasteless capsules containing gut bacteria from healthy volunteers without peanut allergy (搜索). Most participants received 36 pills in a single day, and the treatment did not trigger severe side effects. Five participants also received a four-day course of antibiotics prior to the transplant.
The authors noted several possible explanations for why nine participants did not respond. The donor bacteria may not have become established in non-responders, potentially due to gender-related differences—five of the six responders were men—or because the bacteria were delivered on a single day. Additionally, most non-responders did not receive antibiotics before treatment.
Translational Evidence Across Allergens
In a parallel set of experiments, researchers transplanted gut bacteria from participants' stool samples into mice. Bacteria from human responders protected mice from developing allergies to an egg protein, while bacteria from non-responders did not confer protection.
Because the mouse studies tested a different allergen, the findings suggest the FMT approach may have broader applicability. "The faecal transplant treatment is likely to work for more than just peanut allergies," said study co-author Talal Chatila, an immunologist at Harvard Medical School in Boston, Massachusetts.
Cathryn Nagler, an immunology researcher at the University of Chicago in Illinois, underscored the significance of the translational leap: "Up until now, it's been in mouse models. Now we have people. And that's exciting." She added that "seeing any kind of efficacy in people" is remarkable.
The study builds on prior research linking food allergies to low levels of certain gut bacteria and mouse studies demonstrating that treatment with specific bacterial consortia can keep food allergies in check. These earlier findings led researchers to hypothesize that FMT from non-allergic donors, which delivers a broad range of gut bacteria, might dampen the allergic immune response in affected individuals.