Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients

ConditionFood Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apple pectin (DE 57%)

    Dietary supplement

    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 supplement

    Dietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Pectin intervention groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP.

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.

Time frame
15 months

Secondary outcomes

1

Correlation between the induced changes in oral tolerance to peach and/or peanut and the reactivity in skin prick test (SPT).

Changes in oral tolerance to peach and/or peanut (see Primary outcome). Reactivity in SPT to Pru p 3 and peanut will be defined by the size of the papule area (mm2) measured pre- and post- dietary intervention.

Time frame
15 months
2

Changes in Pru p 3 and Ara h 9 (nsLTP of peach and peanut, respectively) specific immunoglobulin production (IgE and IgG4) induced by the pectin dietary intervention.

Results will be expresses as kUA/L.

Time frame
15 months
3

Changes in Pru p 3 and Ara h 9-specific basophil activation induced by the pectin dietary intervention

Results will be presented as the percentage of activated basophils (CD63+CD203c+CCR3+) and basophil allergen threshold sensitivity (CD-Sens).

Time frame
15 months
4

Maturational changes in Pru p 3 and Ara h 9-specific dendritics cells induced by the pectin dietary intervention.

Results will be expressed as maturation index (MI).

Time frame
15 months

Other outcomes

Sponsors and contacts

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