Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients
NCT06558526 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2025-06-15
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
Interventions
- DIETARY_SUPPLEMENT
-
Apple pectin (DE 57%)
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.
- DIETARY_SUPPLEMENT
-
Placebo
Dietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months.
Sponsors & Collaborators
-
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
lead OTHER
Principal Investigators
-
Natalia Pérez Sánchez, MD, PhD · Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-13
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Spain
Study Locations
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