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

Not Applicable

Active, not recruiting

• Conditions: Crohn Disease
• Interventions: Other: Collection biological sample and analysis

• Registration Number: NCT06324591
• Lead Sponsor: Meyer Children's Hospital IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2024-02-22
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with Chron's Disease	Collection biological sample and analysis	Only patient with Crohn's Disease

Primary Outcome Measures

Name	Time	Method
Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy)	3 years after beginning of the study	Detection of differences in alpha and beta diversity in stool microbiome in various phases of disease course, at diagnosis, remission and after one year of mantainance therapy

Secondary Outcome Measures

Name	Time	Method
Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk	3 years after beginning of the study	Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk
Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification	3 years after beginning of the study	Indentification of different patterns of intestinal microbiome (alpha and beta diversity, microbial richness and relative abundance of microbial species) as a potential biomarker for high and low risk patients

Trial Locations

Locations (3)

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