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
Trial Overview
The Pinpoint Trial is testing the safety and effectiveness of adding a prebiotic fiber (found in grocery stores) to peanut oral immunotherapy for treating peanut allergies. The study will compare the results of this combination therapy against a placebo alongside standard treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Subjects who meet inclusion criteria will be randomized 1:1. The treatment group will receive prebiotic therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the prebiotic. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus prebiotic therapy for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop prebiotic therapy and continue on maintenance POIT in extended observation for approximately 4 years.
Subjects who meet inclusion criteria will be randomized 1:1. The control group will receive placebo therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the placebo. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus placebo for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop placebo and continue on maintenance POIT in extended observation for approximately 4 years.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Published Research Related to This Trial
Citations
1.
drugdiscoverynews.com
drugdiscoverynews.com/prebiotic-gel-relieves-food-allergies-by-altering-gut-microbes-16024Prebiotic gel relieves food allergies by altering gut microbes
The therapy gave allergic mice long-lasting tolerance to common allergens such as peanuts, milk, and egg whites.
Inulin-gel-based oral immunotherapy remodels the small ...
Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study. Lancet 394 ...
3.
news-medical.net
news-medical.net/news/20240712/Inulin-gel-based-oral-immunotherapy-is-effective-in-suppressing-food-allergy-responses-and-anaphylactic-shock.aspxInulin gel-based oral immunotherapy is effective in ...
"Inulin gel-based oral immunotherapy is effective in suppressing food allergy responses and anaphylactic shock". News-Medical. 29 October 2025.
The high dose of inulin exacerbated food allergy through ...
High-inulin supplementation (80 mg per mouse) provoked severe allergic and intestinal inflammatory responses, which were characterized by elevated serum ...
Prebiotics: Mechanisms and Preventive Effects in Allergy - PMC
It has been demonstrated to be effective as a prebiotic in healthy adults, healthy elderly adults, irritable bowel syndrome (IBS) sufferers and ...
Long-term clinical and immunological effects of probiotic ...
No data for long-term outcomes after peanut oral immunotherapy have been published. The natural history of peanut allergy is different from that of egg or milk ...
Long-Term Safety and Efficacy of Prebiotic Enriched Infant ...
The present study thus confirms findings of previous studies reporting that Orafti®Synergy1, at the same dose level, is safe and well-tolerated by neonates [12] ...
A Combination of Prebiotic Inulin and Oligofructose ...
Participants had good compliance with oligofructose-enriched inulin and no adverse effects or symptoms were reported following supplementation. ... Effects of ...
Articles Probiotic peanut oral immunotherapy versus ...
Our study found that both PPOIT and OIT are highly effective at inducing sustained unresponsiveness compared with placebo and led to significant improvement in ...
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