Dietary Intervention in Food Allergy

NCT06386081 | Completed

• 1 other identifier: AC18/00031
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins. Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples.

Conditions

Food Allergy

Keywords

Pectin; Dietary intervention; nsLTP allergy; Immunoregulation; Microbiome

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy of pectin dietary intervention in nsLTP allergic patients

  Clinical efficacy is defined as a significant increase in Pru p 3 (μg) tolerance, measured through DBPCFC performed before and after the pectin intervention, compared to the Placebo.

  16 months

Secondary Outcomes (9)

• Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention

  18 months

• Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention

  18 months

• Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention

  18 months

• Changes in Pru p 3-specific basophil activation induced by pectin intervention

  18 months

• Changes induced in the taxonomic diversity of gut microbiota

  18 months

Study Arms (3)

Citrus pectin dietary intervention group

EXPERIMENTAL

This group will orally take 10 g of citrus pectin with low DE (7,3%) + 5 g of maltodextrin twice a day during two months.

Dietary Supplement: Citrus pectin with low DE

Apple pectin intervention group

EXPERIMENTAL

This group will orally take 10 g of apple pectin with high DE (57%) + 5 g of maltodextrin twice a day during two months.

Dietary Supplement: Apple pectin with high DE

Placebo group

PLACEBO COMPARATOR

This group will orally take placebo (5 g of maltodextrin) twice a day during two months.

Dietary Supplement: Placebo

Interventions

Citrus pectin with low DE DIETARY_SUPPLEMENT

Dietary intervention with citrus pectin with low DE. Participants will orally take the supplement twice a day, after dissolving it in 100ml of water, for 2 months.

Also known as: Classic pectin

Citrus pectin dietary intervention group

Apple pectin with high DE DIETARY_SUPPLEMENT

Dietary intervention with apple pectin with high DE. Participants will orally take the supplement twice a day, after dissolving it in 100ml of water, for 2 months.

Also known as: Herbapekt

Apple pectin intervention group

Placebo DIETARY_SUPPLEMENT

Participants will orally take the placebo (maltodextrin) twice a day, after dissolving it in 100ml of water, for 2 months. Maltodextrin is highly digestible and in small amounts will have limited impact on gut microbiome.

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)
• Sensitization to Pru p 3 by positive skin prick test (SPT wheal area \>7 mm2) and specific IgE (sIgE \>0.35 kU/L)
• Positive DBPCFC (Sampson 2012) with peach juice
• Signed informed consent

You may not qualify if:

• Any clinical condition contraindicating performance of DBPCFC
• A negative result in the DBPCFC
• Lactation
• Active infections
• Acute/chronic inflammatory, autoimmune, and/or oncological diseases
• Diabetes
• Obesity
• Severe immunodeficiency
• Metabolic syndrome
• Alcohol disorder
• Mental illness
• Increased liver parameters and any liver disease
• Smoking habit
• Enzymatic deficiency
• Being vegetarian and taking vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months, and immunomodulators and/or immunotherapy 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, Spain

Location

Related Publications (10)

• Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.

  PMID: 24390308 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

• Krautkramer KA, Kreznar JH, Romano KA, Vivas EI, Barrett-Wilt GA, Rabaglia ME, Keller MP, Attie AD, Rey FE, Denu JM. Diet-Microbiota Interactions Mediate Global Epigenetic Programming in Multiple Host Tissues. Mol Cell. 2016 Dec 1;64(5):982-992. doi: 10.1016/j.molcel.2016.10.025. Epub 2016 Nov 23.

  PMID: 27889451 BACKGROUND

• Villasenor A, Rosace D, Obeso D, Perez-Gordo M, Chivato T, Barbas C, Barber D, Escribese MM. Allergic asthma: an overview of metabolomic strategies leading to the identification of biomarkers in the field. Clin Exp Allergy. 2017 Apr;47(4):442-456. doi: 10.1111/cea.12902.

  PMID: 28160515 BACKGROUND

• Zhang Z, Shi L, Pang W, Liu W, Li J, Wang H, Shi G. Dietary Fiber Intake Regulates Intestinal Microflora and Inhibits Ovalbumin-Induced Allergic Airway Inflammation in a Mouse Model. PLoS One. 2016 Feb 12;11(2):e0147778. doi: 10.1371/journal.pone.0147778. eCollection 2016.

  PMID: 26872019 BACKGROUND

• Tian L, Bruggeman G, van den Berg M, Borewicz K, Scheurink AJ, Bruininx E, de Vos P, Smidt H, Schols HA, Gruppen H. Effects of pectin on fermentation characteristics, carbohydrate utilization, and microbial community composition in the gastrointestinal tract of weaning pigs. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600186. Epub 2016 Jun 20.

  PMID: 27198846 BACKGROUND

• Savage J, Johns CB. Food allergy: epidemiology and natural history. Immunol Allergy Clin North Am. 2015 Feb;35(1):45-59. doi: 10.1016/j.iac.2014.09.004. Epub 2014 Nov 21.

  PMID: 25459576 BACKGROUND

• Fernandez-Rivas M, Bolhaar S, Gonzalez-Mancebo E, Asero R, van Leeuwen A, Bohle B, Ma Y, Ebner C, Rigby N, Sancho AI, Miles S, Zuidmeer L, Knulst A, Breiteneder H, Mills C, Hoffmann-Sommergruber K, van Ree R. Apple allergy across Europe: how allergen sensitization profiles determine the clinical expression of allergies to plant foods. J Allergy Clin Immunol. 2006 Aug;118(2):481-8. doi: 10.1016/j.jaci.2006.05.012. Epub 2006 Jun 27.

  PMID: 16890775 BACKGROUND

• Gomez F, Aranda A, Campo P, Diaz-Perales A, Blanca-Lopez N, Perkins J, Garrido M, Blanca M, Mayorga C, Torres MJ. High prevalence of lipid transfer protein sensitization in apple allergic patients with systemic symptoms. PLoS One. 2014 Sep 11;9(9):e107304. doi: 10.1371/journal.pone.0107304. eCollection 2014.

  PMID: 25210741 BACKGROUND

• Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.

  PMID: 23195525 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

citrus pectin

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• María José Torres, MD, PhD

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

  PRINCIPAL INVESTIGATOR

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: April 4, 2024
• First Posted: April 26, 2024
• Study Start: January 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-03

Data Sharing

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

Locations

ES (1)