Prebiotics for Peanut Allergy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding a fiber-based prebiotic to peanut oral immunotherapy (a treatment to build tolerance to peanuts) is safe and effective for treating peanut allergies. Participants will receive either the prebiotic (oligofructose-enriched inulin, also known as Prebiotin) or a placebo alongside standard peanut therapy to determine if the prebiotic enhances treatment outcomes. The trial targets individuals aged 4 to 17 years with a known peanut allergy who experience symptoms from small amounts of peanut protein. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using oral steroids, any type of immunotherapy, or certain other medications. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that prebiotics are generally safe and easy to tolerate. One study found that people who took prebiotic fibers, such as those in bananas and garlic, did not experience negative effects. Another study demonstrated that a prebiotic called Orafti®Synergy1 was safe for infants.
Although these studies do not specifically address peanut allergy treatments, they suggest that prebiotics, a type of fiber, are usually safe for most people. This trial is in its early stages and primarily focuses on gathering safety information. While complete data on its safety for peanut allergies is not yet available, early trials suggest that the treatment is potentially safe enough for further testing.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for peanut allergies, which often involves strict avoidance and emergency medications like epinephrine, prebiotics offer a novel approach. Researchers are excited about prebiotics because they may enhance the effectiveness of peanut oral immunotherapy (POIT). By potentially improving gut health, prebiotics could help the immune system tolerate peanuts over time, reducing the severity of allergic reactions. This combination therapy could represent a significant step forward in making peanut allergy management more proactive and less reliant on emergency interventions.
What evidence suggests that this prebiotic might be an effective treatment for peanut allergy?
Studies have shown that prebiotics can help manage food allergies by altering gut bacteria. For instance, allergic mice given prebiotic treatment became tolerant to allergens like peanuts. Another study found that using an inulin gel—a type of prebiotic—reduced allergic reactions and prevented severe responses. However, very high doses of inulin might worsen allergies in some cases. In this trial, participants in the treatment group will receive prebiotic therapy alongside peanut oral immunotherapy (POIT), while the control group will receive a placebo with their POIT. Overall, early evidence suggests that prebiotics could be beneficial when combined with peanut oral immunotherapy, but more research is needed to confirm these effects in humans.26789
Who Is on the Research Team?
Christina Ciaccio, MD MSc
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for children aged 4 to 17 with a confirmed peanut allergy, as shown by specific immune markers and reactions in tests. They must have had symptoms at low doses of peanut protein or meet other criteria indicating sensitivity to peanuts. Participants cannot have certain chronic diseases, be on immunomodulatory medications, or be involved in another interventional study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prebiotic/Placebo Phase
Participants receive prebiotic or placebo therapy for 30 days before starting oral immunotherapy
Oral Immunotherapy Up-dosing
Participants undergo peanut oral immunotherapy (POIT) up-dosing for approximately 180 days
Maintenance Phase
Participants continue on maintenance POIT plus prebiotic or placebo for an additional 180 days
Extended Observation
Participants continue on maintenance POIT in extended observation for approximately 4 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Prebiotic
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor