320 Participants Needed

Supervised Feeding for Peanut Allergy

ZA
CR
Overseen ByCorinna Rea, MD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Supervised Clinical Feeding Intervention for peanut allergy?

Research shows that oral immunotherapy (OIT) for peanut allergy, which involves gradually increasing exposure to peanut protein, has been effective in helping children and adolescents tolerate higher amounts of peanut protein without severe allergic reactions. This approach has been shown to reduce symptom severity and improve quality of life for patients and their families.12345

Is supervised feeding for peanut allergy generally safe for humans?

Research on peanut oral immunotherapy (a treatment involving controlled exposure to peanut allergens) shows that safety can depend on factors like age and existing allergies. While it can help build tolerance, it's important to discuss potential risks with a doctor, as reactions can vary.15678

How does the Supervised Clinical Feeding Intervention treatment for peanut allergy differ from other treatments?

The Supervised Clinical Feeding Intervention for peanut allergy is unique because it involves a supervised approach to gradually introducing peanuts to those with allergies, aiming to desensitize them and reduce the risk of severe reactions. This method contrasts with traditional avoidance strategies and offers a proactive way to manage peanut allergies by building tolerance.5691011

What is the purpose of this trial?

Peanut allergies affect approximately 2.5% of children; are associated with significant mortality, morbidity, and economic costs; and often lead to persistent peanut allergies in adulthood. We now know however that early introduction of peanut products to infants prior to age 7 months and maintained in the diet regularly significantly reduces the rate of peanut allergies. Unfortunately, recent research shows that even when parents know the recommendations to feed peanut products early and often, \<50% of parents report introducing peanuts by age 9 months, \<45% are offering peanut products several times a week, and \<20% are offering the recommended 2 teaspoons at each feeding. Many parents cite a fear of reactions or a lack of knowledge on how to safely feed peanut products at this age. While there are recommendations to offer the first feeding in clinic this has not been widely implemented in general pediatrics clinics and we have no research to say this is an effective way to increase peanut consumption at home. This research is being conducted to assess the effectiveness of a supervised peanut feeding clinic in a pediatric office to increase rate of guideline recommended peanut consumption in infants by 9 months of age.

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Families will receive guidance about early peanut introduction via handout as well as a supervised feeding visit.
Group II: ControlActive Control1 Intervention
Families will receive guidance about early peanut introduction via a handout.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

References

Risk factors associated with safety of preschool peanut oral immunotherapy. [2023]
Long-term safety and immunologic outcomes of daily oral immunotherapy for peanut allergy. [2023]
Transitioning peanut oral immunotherapy to clinical practice. [2022]
Current management and use of oral immunotherapy in the United States for patients with peanut allergy. [2020]
Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. [2023]
Development of an innovative curriculum for paediatricians on peanut allergy prevention: How do we address current guidelines? [2023]
Inadvertent exposures in children with peanut allergy. [2012]
Early Peanut Introduction in Primary Care: Evaluation of a Multicomponent Intervention. [2023]
The Case for Prompt Salvage Infant Peanut Oral Immunotherapy Following Failed Primary Prevention. [2023]
A Practical, Stepwise Approach to Peanut Oral Immunotherapy in Clinical Practice: Benefits and Risks. [2021]
11.Bosnia and Herzegovinapubmed.ncbi.nlm.nih.gov
Peanut Allergy - No Longer a Life Sentence. [2021]
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