Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06558526

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

Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2025-06-15

62

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Food allergy to corn.
  • Food allergy to peanut due to sensitization to storage proteins.
  • Previous or active treatment with sublingual immunotherapy to Pru p 3.
  • Pregnancy or 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.
  • Forced expiratory volume in 1 second (FEV1) less than 70%.
  • Treatment with immunomodulators in the last five years.
  • Use of vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months.
  • Any clinical condition contraindicating performance of double-blind placebo-controlled food challenges.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain, 29009

Actively Recruiting

Loading map...

Research Team

N

Natalia Pérez Sánchez, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here