An interventional study of Apple pectin (DE 57%) and Placebo in Food Allergy, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
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.
Patients of 3 different Allergy Units with clinical history of allergic reactions with peach and with/without reactions with peanut due to sensitization to nsLTP will be informed about the intervention study and potential risks. After obtention of written informed consent, screening phase evaluation will be performed (skin prick tests (SPT), obtention of blood and feces samples and double-blind placebo-controlled food challenges (DBPCFC) with peach and peanut). Participants who meet the eligibility requirements will be randomized in a ratio 1:1 to pectin (apple pectin 10 mg + maltodextrin 5 mg; once daily) or placebo (maltodextrin 5 mg; once daily). The dietary intervention will last 6 months and a follow-up visit in month 3 will be performed. After completing the dietary intervention all participants will be clinically assessed (SPT and DBPCFC) and new blood and feces samples will be collected. Finally, patients who receive the active will be clinically evaluated with DBPCFC to peach and peanut after 6 months of completing the dietary intervention. Also, new blood and feces samples will be obtained.
The main objective is to analyze the clinical efficacy of a pectin dietary supplement administered once a day for 6 months as a treatment for nsLTP allergy in a randomized double-blind placebo-controlled multicenter intervention study. In addition, the investigators will study changes in clinical reactivity to nsLTP and the immunomodulatory effect (immunological humoral and cellular, metabolomics and microbiota profiles). Furthermore, long-term effects of the dietary intervention will be analyzed in participants from the active group (pectin) 6 months after completing the intervention.
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This study's planned enrollment of 62 is close to the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
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Exclusion Criteria:
This group will orally take 10 g of apple pectin (DE 57%) + 5 g of maltodextrin once a day during 6 months.
Dietary Supplement: Apple pectin (DE 57%)
This group will orally take 5 g of maltodextrin once a day during 6 months.
Dietary Supplement: Placebo
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.
Also known as: Herbapekt
Dietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months.
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
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
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
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
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
Pru p 3 and Ara h 9-specific proliferative response of different lymphocytes cell subpopulations after the pectin dietary intervention.
The specific proliferation responses of different lymphocytes subpopulations will be measured: Th1, Th2, Th9, and Plasma-cells/IgE+, T regulatory cells (Treg), Treg/IL10+ and B regulatory cells/ IL10+. The results will be expressed as fold change of proliferation index (PI).
Time frame: 15 months
Changes on gastrointestinal microbiota induced by the pectin dietary intervention.
Analysis of bacteria composition: relative abundance (%) and alpha-, beta diversity as Jensen Shannon divergence (JSD) (PChao1 vs PChao2).
Time frame: 15 months
Changes on feces metabolome induced by the pectin dietary intervention.
Metabolomic profile from feces samples will be analyzed using a combination of untargeted mass spectrometry techniques: liquid chromatography-mass spectrometry (LC-ESI-QTOF-MS) and capillary electrophoresis-mass spectrometry (CE-TOF-MS). Results will be expressed as μg/g.
Time frame: 15 months
Changes on serum metabolome induced by the pectin dietary intervention.
Metabolomic profile from serum samples will be analyzed by a combination of liquid chromatography-mass spectrometry (LC-MS) and gas chromatography coupled to mass spectrometry (GC-MS). Results will be expressed as μg/mL.
Time frame: 15 months
Pectin dietary intervention long-term clinical efficacy.
Peach and peanut oral tolerance after 6 months of completing the dietary intervention with the active (pectin) will be determine through DBPCFCs.
Time frame: 12 months
Pectin dietary intervention long-term effect on the immunological profile.
Determination and analysis of Pru p 3 and Ara h 9-specific IgE and IgG4 production, basophil activation, dendritic cell maturation and proliferative response of different lymphocytes cell subpopulations, after 6 months of completing the dietary intervention with the active (pectin). Each determination will be performed and measured as same as for the related previous outcomes mentioned.
Time frame: 12 months
Pectin dietary intervention long-term effect on the gastrointestinal microbiota.
Analysis of gastrointestinal microbiota composition after 6 months of completing the dietary intervention with the active (pectin). Relative abundance (%) and alpha-, beta diversity as Jensen Shannon divergence (JSD) (PChao1 vs PChao2).
Time frame: 12 months
Pectin dietary intervention long-term effect on feces metabolome.
Analysis by a combination of mass spectrometry techniques after 6 months of completing the dietary intervention with the active (pectin). Results will be expressed as μg/g.
Time frame: 12 months
Pectin dietary intervention long-term effect on serum metabolome.
Analysis by a combination of mass spectrometry techniques after 6 months of completing the dietary intervention with the active (pectin). Results will be expressed as μg/mL.
Time frame: 12 months
Plan to share: Yes — The present study will adhere to FAIR (Findable, Accessible, Interoperable, and Reusable data) data principles. We will make all data available as appropriate, including a detailed description of protocols and analysis pipelines, to ensure that results can be reproduced, and to facilitate further analysis and development of this work by other groups. We will make the data preserved accessible, and used in accordance with scientific norms of fair attribution and use.
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud