Prebiotics for Peanut Allergy

Recruiting at 1 trial location

Overseen By Toni A Ramirez, BS

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Chicago

Must not be taking: Oral steroids, Biologics

Disqualifiers: Chronic disease, Autoimmune, Cardiovascular, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.

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.

What data supports the effectiveness of the treatment Prebiotics for Peanut Allergy?

Research suggests that prebiotics like inulin can help create a more tolerant immune environment and improve gut health, which may reduce food allergy symptoms. Studies in mice have shown that prebiotics can promote beneficial gut bacteria and reduce allergy symptoms, indicating potential benefits for peanut allergies. ^{1 2 3 4 5}

Is prebiotic supplementation safe for humans?

Prebiotics, like fructo-oligosaccharides and inulin, are generally considered safe and can positively affect gut bacteria, which may help with allergies. Studies in infants and animal models suggest they can improve gut health and immune tolerance without significant safety concerns. ^{1 2 4 5 6}

How does the prebiotic treatment for peanut allergy differ from other treatments?

This prebiotic treatment for peanut allergy is unique because it focuses on altering the gut microbiota to promote immune tolerance, unlike traditional treatments that often involve avoiding peanuts or using medications to manage symptoms. Prebiotics like galacto-oligosaccharides and inulin help reinforce the gut barrier and modulate the immune system, potentially preventing allergies from developing. ^{1 2 4 7 8}

Research Team

Christina Ciaccio, MD MSc

Principal Investigator

University of Chicago

Eligibility Criteria

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

Written informed consent from parent/guardian

I have given my written agreement to participate if I am older than 7.

A convincing clinical history of peanut allergy

Exclusion Criteria

I have no history of autoimmune, heart, chronic lung diseases (except asthma), cancer, mental illness, or inflammatory gut conditions.

History of recurrent idiopathic or virally induced urticaria, angioedema or anaphylaxis

I am currently using immunotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prebiotic/Placebo Phase

Participants receive prebiotic or placebo therapy for 30 days before starting oral immunotherapy

4 weeks

Oral Immunotherapy Up-dosing

Participants undergo peanut oral immunotherapy (POIT) up-dosing for approximately 180 days

26 weeks

Maintenance Phase

Participants continue on maintenance POIT plus prebiotic or placebo for an additional 180 days

26 weeks

Extended Observation

Participants continue on maintenance POIT in extended observation for approximately 4 years

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Infants consuming formula with prebiotics (galacto-oligosaccharides and fructo-oligosaccharides) showed a significantly higher abundance and proportion of beneficial bifidobacteria compared to those without prebiotics, indicating a positive effect on gut microbiota composition.

The prebiotic-containing formula was well tolerated and resulted in lower fecal pH, but did not affect stool patterns, tolerance, or growth compared to the control group, suggesting it is a safe option for infant nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prebiotic-containing infant formula on gastrointestinal tolerance and fecal microbiota in a randomized controlled trial. Holscher, HD., Faust, KL., Czerkies, LA., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Prebiotic Supplementation During Gestation Induces a Tolerogenic Environment and a Protective Microbiota in Offspring Mitigating Food Allergy. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Altered microbial community structure and metabolism in cow's milk allergic mice treated with oral immunotherapy and fructo-oligosaccharides. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The effect of baked milk on accelerating unheated cow's milk tolerance: A control randomized clinical trial. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Probiotics, prebiotics and food allergy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A synbiotic-containing amino-acid-based formula improves gut microbiota in non-IgE-mediated allergic infants. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of prebiotic-containing infant formula on gastrointestinal tolerance and fecal microbiota in a randomized controlled trial. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prebiotics: Mechanisms and Preventive Effects in Allergy. [2020]

8. Denmark pubmed.ncbi.nlm.nih.gov

Attenuation of food allergy symptoms following treatment with human milk oligosaccharides in a mouse model. [2022]