Daily apple pectin for adults with nsLTP-related peach and peanut allergy
Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up
This study will test whether taking apple pectin every day for six months can increase tolerance to peach (and possibly peanut) and change the gut microbiome in adults with nsLTP allergy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Málaga, Málaga) |
| Trial ID | NCT06558526 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a clear clinical history of allergic reaction to peach, confirmed sensitization to Pru p 3 by skin prick test and specific IgE, and a positive DBPCFC to peach (and to peanut if clinically relevant) are the intended participants.
Not a fit: Patients whose peanut allergy is due to storage-protein sensitization, those with food allergy to corn, pregnant or lactating people, or those with active infections, significant autoimmune, oncologic, liver, metabolic disorders, or severe immunodeficiency are unlikely to be eligible and may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, daily pectin could increase tolerance to nsLTP-containing foods and produce lasting immune and microbiome changes that reduce allergic reactions.
How similar studies have performed: Preliminary pilot data from the investigators showed increased peach tolerance and microbiota changes after two months of pectin, but the approach is relatively novel and lacks large-scale confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Málaga, Málaga
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.