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

NCT06558526 | Recruiting

• 1 other identifier: PI23/00820
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Allergy

Keywords

nsLTP allergy; Dietary intervention; Pectin; Microbiome; Immunomodulation; Food allergy treatment

Outcome Measures

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.

  15 months

Secondary Outcomes (13)

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

  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.

  15 months

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

  15 months

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

  15 months

• Pru p 3 and Ara h 9-specific proliferative response of different lymphocytes cell subpopulations after the pectin dietary intervention.

  15 months

Study Arms (2)

Pectin intervention group

EXPERIMENTAL

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%)

Placebo group

PLACEBO COMPARATOR

This group will orally take 5 g of maltodextrin once a day during 6 months.

Dietary Supplement: Placebo

Interventions

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.

Also known as: Herbapekt

Pectin intervention group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29009, Spain

RECRUITING

Related Publications (7)

• Fernandez-Rivas M, Gonzalez-Mancebo E, Rodriguez-Perez R, Benito C, Sanchez-Monge R, Salcedo G, Alonso MD, Rosado A, Tejedor MA, Vila C, Casas ML. Clinically relevant peach allergy is related to peach lipid transfer protein, Pru p 3, in the Spanish population. J Allergy Clin Immunol. 2003 Oct;112(4):789-95. doi: 10.1016/S0091.

  PMID: 14564363 BACKGROUND

• Skypala IJ, Asero R, Barber D, Cecchi L, Diaz Perales A, Hoffmann-Sommergruber K, Pastorello EA, Swoboda I, Bartra J, Ebo DG, Faber MA, Fernandez-Rivas M, Gomez F, Konstantinopoulos AP, Luengo O, van Ree R, Scala E, Till SJ; European Academy of Allergy; Clinical Immunology (EAACI) Task Force: Non-specific Lipid Transfer Protein Allergy Across Europe. Non-specific lipid-transfer proteins: Allergen structure and function, cross-reactivity, sensitization, and epidemiology. Clin Transl Allergy. 2021 May 18;11(3):e12010. doi: 10.1002/clt2.12010. eCollection 2021 May.

  PMID: 34025983 BACKGROUND

• Noval Rivas M, Burton OT, Wise P, Zhang YQ, Hobson SA, Garcia Lloret M, Chehoud C, Kuczynski J, DeSantis T, Warrington J, Hyde ER, Petrosino JF, Gerber GK, Bry L, Oettgen HC, Mazmanian SK, Chatila TA. A microbiota signature associated with experimental food allergy promotes allergic sensitization and anaphylaxis. J Allergy Clin Immunol. 2013 Jan;131(1):201-12. doi: 10.1016/j.jaci.2012.10.026. Epub 2012 Nov 30.

  PMID: 23201093 BACKGROUND

• Bunyavanich S, Berin MC. Food allergy and the microbiome: Current understandings and future directions. J Allergy Clin Immunol. 2019 Dec;144(6):1468-1477. doi: 10.1016/j.jaci.2019.10.019.

  PMID: 31812181 BACKGROUND

• Zhu Z, Zhu B, Hu C, Liu Y, Wang X, Zhang J, Wang F, Zhu M. Short-chain fatty acids as a target for prevention against food allergy by regulatory T cells. JGH Open. 2019 Jan 8;3(3):190-195. doi: 10.1002/jgh3.12130. eCollection 2019 Jun.

  PMID: 31276034 BACKGROUND

• Tan J, McKenzie C, Vuillermin PJ, Goverse G, Vinuesa CG, Mebius RE, Macia L, Mackay CR. Dietary Fiber and Bacterial SCFA Enhance Oral Tolerance and Protect against Food Allergy through Diverse Cellular Pathways. Cell Rep. 2016 Jun 21;15(12):2809-24. doi: 10.1016/j.celrep.2016.05.047.

  PMID: 27332875 BACKGROUND

• Steigerwald H, Blanco-Perez F, Albrecht M, Bender C, Wangorsch A, Endress HU, Bunzel M, Mayorga C, Torres MJ, Scheurer S, Vieths S. Does the Food Ingredient Pectin Provide a Risk for Patients Allergic to Non-Specific Lipid-Transfer Proteins? Foods. 2021 Dec 21;11(1):13. doi: 10.3390/foods11010013.

  PMID: 35010137 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Natalia Pérez Sánchez, MD, PhD

  Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Pérez Sánchez, MD, PhD

CONTACT

+34 951290224; nataliai.perez.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment will be blinded to the participants and research team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be released upon publication and preserved for a minimum of 10 years.
• Access Criteria: Free access.

Locations

ES (1)