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

NCT ID: NCT06324591

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient with Chron's Disease

Only patient with Crohn's Disease

Group Type: OTHER

Collection biological sample and analysis

Intervention Type: OTHER

collection of a stool sample collected at clinical practice check-ups during the first year after diagnosis of Crohn's disease. This is followed by the evaluation of clinical, laboratory and instrumental data at the time of diagnosis

Interventions

Collection biological sample and analysis

collection of a stool sample collected at clinical practice check-ups during the first year after diagnosis of Crohn's disease. This is followed by the evaluation of clinical, laboratory and instrumental data at the time of diagnosis

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Paolo Lionetti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Lionetti

Role: PRINCIPAL_INVESTIGATOR

Meyer Children's Hospital IRCCS

Locations

Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine

Graz, , Austria

Ospedale Maggiore-Azienda Usl Di Bologna

Bologna, , Italy

Meyer Children's Hospital IRCCS

Florence, , Italy

Countries

Austria; Italy

Other Identifiers

RISKCROHNBIOM

Identifier Type: -

Identifier Source: org_study_id