Apple pectin (DE 57%): Dietary intervention with apple pectin. Participants will orally take the supplement once a day, after dissolving it in 100 ml of water, for 6 months.
Placebo: Dietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months.
Study summary
Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodulatory effect. Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach, and changes in the microbiota compared to the group of patients treated with placebo. In this project, the investigators aim to study these clinical effects and the involved mechanisms. Moreover, the long-term effect (clinical reactivity to nsLTP and immunomodulatory effect) of the dietary intervention will be prospectively evaluated 6 months after the intervention.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP. — 15 months Clinical efficacy will be defined as an increase in oral tolerance to peach and/or peanut determined through the DBPCFCs performed pre- and post- dietary intervention, compared to the Placebo.
Trial sites (1)
Facility
City
Region
Status
Hospital Regional Universitario de Málaga
Málaga
Málaga
Recruiting
More Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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