Supervised Feeding for Peanut Allergy

Overseen By Corinna Rea, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Non-English speaking, not eating solids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supervised feeding clinic to determine if it helps parents introduce peanuts to their babies safely and effectively. The goal is to increase peanut consumption in infants by 9 months of age, potentially lowering the risk of developing peanut allergies. Participants will receive guidance either through a handout or a handout plus a supervised feeding session (Supervised Clinical Feeding Intervention). The trial seeks infants aged 4-6 months who have not yet tried peanuts and show no signs of peanut allergy. As an unphased trial, this study offers parents a unique opportunity to contribute to important research that could help prevent peanut allergies in children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this supervised clinical feeding intervention is safe for infants?

Research has shown that giving peanuts to children early can greatly reduce their chances of developing a peanut allergy. In the Learning Early About Peanut Allergy (LEAP) trial, children who began eating peanuts early had a lower risk of being allergic by age 5. Another study found that after a carefully monitored feeding program, 91% of babies could eat peanuts without allergic reactions.

These results suggest that introducing peanuts early and under supervision is generally safe for babies. Although many parents worry about allergies, evidence indicates that supervised feeding helps babies safely build tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the supervised feeding intervention for peanut allergy because it offers a proactive approach to allergy prevention. Unlike traditional methods that may involve avoidance or oral immunotherapy, this method focuses on early and controlled exposure. By incorporating supervised feeding sessions, this approach aims to safely introduce peanuts to children at risk, potentially reducing the development of severe allergies. This technique could make managing peanut allergies more effective and accessible for families, paving the way for preventive strategies rather than reactive ones.

What evidence suggests that this supervised clinical feeding intervention is effective for increasing peanut consumption in infants?

Research has shown that introducing peanuts early in a child's diet can significantly reduce the risk of developing a peanut allergy. The LEAP trial found that children who began eating peanuts early were less likely to have peanut allergies by age 5. Studies also indicate that even children with strong peanut allergies can safely consume peanuts if they start with small amounts and gradually increase. Additionally, among children who had reactions at home, 65% did not react when tested in a controlled setting, and 96% could eventually eat peanuts safely. In this trial, some families will receive guidance about early peanut introduction via a handout, while others will also participate in a supervised feeding visit. These findings suggest that supervised clinical feeding can help more infants eat peanuts safely and reduce allergy risks. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for infants who have not yet reached 7 months of age, aiming to prevent peanut allergies by introducing peanut products early. Parents must be willing to follow the feeding intervention and guidelines provided. Infants with known severe food allergies or conditions that could interfere with the study are likely excluded.

Inclusion Criteria

My baby is 4-6 months old, eats orally, hasn't tried peanuts, and shows no signs of peanut allergy.

Exclusion Criteria

Evidence of peanut allergy.

Non-English speaking

Not eating solid food

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Intervention

Participants in the intervention arm are invited to a supervised feeding clinic visit where infants are fed peanut butter in a monitored clinical setting.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for peanut introduction and frequency of feeding at home.

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Supervised Clinical Feeding Intervention

Trial Overview The study tests whether a supervised feeding clinic can help increase the rate at which infants consume peanuts as recommended by guidelines. It compares results from parents following a structured handout versus those participating in a supervised clinical intervention.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Families will receive guidance about early peanut introduction via handout as well as a supervised feeding visit.

Group II: Control Active Control 1 Intervention

Families will receive guidance about early peanut introduction via a handout.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Citations

1. mountsinai.org mountsinai.org/about/newsroom/2025/eating-gradually-increasing-doses-of-store-bought-peanut-butter-enables-children-with-high-threshold-allergy-to-safely-consume-peanuts

Eating Gradually Increasing Doses of Store-Bought Peanut ... Children with high-threshold peanut allergy who ate gradually larger doses of store-bought peanut butter achieved significantly higher and long ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10932885/

Risk subgroups and intervention effects among infants at ... The Learning Early About Peanut Allergy (LEAP) trial showed that early dietary introduction of peanut reduced the risk of developing peanut allergy by age 60 ...

3. trials.foodallergy.org trials.foodallergy.org/trials/NCT06892132

Evaluation of a Supervised Clinical Feeding Intervention For our secondary aim we will treat our outcome as a dichotomous variable (0 = feeding peanuts 2 or fewer times a week and 1 = feeding peanuts 3 or more times ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213219824008808

Successful Introduction of Peanut in Sensitized Infants With ... These data show that 65% of infants with reported reactions to peanut at home have negative OFCs. In those children, peanut could be introduced safely, and 96% ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06262867

Study Details | NCT06262867 | Early Allergen System ... The Learning Early About Peanut (LEAP) study demonstrated a significant reduction in peanut allergy by introducing peanuts early, irrespective of baseline ...

6. newsroom.clevelandclinic.org newsroom.clevelandclinic.org/2023/08/03/cleveland-clinic-researchers-confirm-early-intervention-curbs-peanut-allergies-in-babies

Cleveland Clinic Researchers Confirm Early Intervention ... After completing the challenge, 91% of them could tolerate peanuts without triggering any allergic reactions. “Our study shows that the ...

7. withpower.com withpower.com/trial/phase-peanut-hypersensitivity-4-2025-d3d8b

Supervised Feeding for Peanut Allergy · Info for Participants This trial is for infants who have not yet reached 7 months of age, aiming to prevent peanut allergies by introducing peanut products early.