Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients

Meyer Children's Hospital IRCCS

Status: Active, not recruiting

Conditions: Crohn Disease

Treatments: Other: Collection biological sample and analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06324591

RISKCROHNBIOM

Details and patient eligibility

About

Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.

The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course.

Enrollment: 30 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children/young people aged between 6 and 18 years with newly diagnosed CM according to recognised diagnostic criteria
• Obtaining informed consent

Exclusion criteria

• Refusal to participate in the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

patient with Chron's Disease

Other group

Description:

Only patient with Crohn's Disease

Treatment:

Other: Collection biological sample and analysis