Daily apple pectin for adults with nsLTP-related peach and peanut allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial enrolls adults with confirmed nsLTP (Pru p 3)–mediated peach allergy, with or without peanut reactivity. Participants are randomized 1:1 to receive daily apple pectin or placebo for six months, with a mid-treatment visit at month 3 and post-treatment assessments including skin prick tests, double-blind placebo-controlled food challenges to peach and peanut, and collection of blood and fecal samples. The study will compare changes in clinical reactivity, specific IgE and cellular immune markers, and gut microbiome composition between groups. Participants who received active pectin will also be re-evaluated with food challenges and samples six months after finishing the intervention to assess durability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and/or systemic symptoms) and with or without clinical history of food allergy with peanut.
* Sensitization to Pru p 3 by positive skin prick test (SPT wheal area \>7 mm2) and specific IgE (sIgE \>0.35 kUA/L)
* Positive DBPCFC with peach juice.
* If clinical history of food allergy with peanut, sensitization must be confirmed by positive SPT to peanut and sIgE \>0.35 kUA/L to Ara h 9 and clinical reactivity through a positive DBPCFC with peanut.
* Signed informed consent.

Exclusion Criteria:

* Food allergy to corn.
* Food allergy to peanut due to sensitization to storage proteins.
* Previous/active treatment with sublingual immunotherapy to Pru p 3.
* Pregnancy/lactation.
* Active infections.
* Inflammatory, autoimmune, and/or oncological diseases.
* Severe immunodeficiency.
* Metabolic syndrome.
* Increased liver parameters and/or any liver disease.
* Alcohol disorder.
* Mental illness.
* Mast cell activation syndrome.
* Severe atopic dermatitis.
* FEV1 \< 70%
* Treatment with immunomodulators in the last five years.
* Vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months.
* Any clinical condition contraindicating performance of DBPCFC.

Where it's running

• Hospital Regional Universitario de Málaga
  Málaga, Málaga, Spain Recruiting

Study contacts

• Principal investigator: Natalia Pérez Sánchez, MD, PhD — Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
• Study coordinator: Natalia Pérez Sánchez, MD, PhD
• Email: nataliai.perez.sspa@juntadeandalucia.es
• Phone: +34 951290224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.