Evaluation of Alterations in the Gut Microbiota in Pediatric Bronchial Asthma

NCT06842836 | Active Not Recruiting

• 1 other identifier: ASO.Ped.23.11
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma constitutes a major chronic noncommunicable disease, globally it affects about 300 million people and the incidence has been steadily increasing in recent decades; it affects about 10% of children and is the leading chronic disease in childhood. The microbiota constitutes the collection of all microorganisms-bacteria, viruses, fungi, protozoa-that live in symbiosis with our bodies. Disruption of the microbiota during this critical period of development can cause asthma, allergies, and other immunological disorders. Therefore, it can be an important environmental factor that determines the transition of health to disease. The aim of the intended study is to evaluate and analyze the presence of possible alterations in the gut microbiota in a cohort of pediatric asthmatic subjects by collecting fecal samples.

Conditions

Asthma Bronchiale

Keywords

microbiota

Outcome Measures

Primary Outcomes (1)

• Qualitative changes in the gut microbiota

  The gut microbiota will be analyzed from a fecal sample using the 16S ribosomal RNA gene as the target of hypervariable regions V3-V6 (QIAamp® PowerFecal® Pro DNA Kit Qiagen, Germany) and using the Illumina® iSeq-100 platform for NGS sequencing.

  Baseline

Secondary Outcomes (2)

• Quantitative characterization of microbial species of gut microbiota

  Baseline

• Mediterranean Diet Quality Index in children and adolescents

  Baseline

Study Arms (1)

Study cohort

Pediatric subjects aged 6 to 9 years, diagnosed with intermittent or mild persistent bronchial asthma, referred to the pediatric outpatient clinic of the Children's Hospital of Alessandria will be enrolled in the study

Other: Study intervention

Interventions

Study intervention OTHER

From the date of study authorization, the principal investigator, together with his specially identified collaborators, will proceed to identify patients who meet the inclusion criteria. Then, during the first follow-up visit, the principal investigator, or one of his co-investigators, will deliver the informed consent to the parent(s) of the minor subject candidate for enrollment in the study, explaining all the characteristics and evaluations stipulated in the protocol and answering any questions. After the informed consent is signed, patients will be enrolled and the data required to conduct the study will be collected, and a fecal sample will be requested specifically for the conduct of the study. At the same time, completion of the KIDMED (Mediterranean Diet Quality Index in children and adolescents) questionnaire will be requested.

Study cohort

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 25 pediatric subjects aged 6 to 9 years, diagnosed with intermittent or mild persistent bronchial asthma, referred to the pediatric outpatient clinic of the Children's Hospital of Alexandria will be enrolled in the study

You may qualify if:

• Signature of informed consent by Parents;
• Age between 6 and 9 years;
• Confirmed diagnosis of bronchial asthma at Alessandria Children's Hospital through spirometry investigation;
• Bronchial asthma classified as intermittent or mild persistent;
• Patients followed at the outpatient clinics of the SC Pediatrics of AOU SS Antonio e Biagio and C. Arrigo of Alessandria.

You may not qualify if:

• Taking prolonged systemic therapy for the treatment of bronchial asthma;
• Bronchial asthma classified as moderate persistent or severe persistent;
• Insurmountable language barrier.
• Ongoing antibiotic intake.

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

SSD Laboratori di Ricerca (DAIRI) - AOU Alessandria

Alessandria, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: May 6, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)