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

Crohn Disease Clinical Trial

Official title:

Multicentre Observational Cohort Study in Newly Diagnosed Crohn's Disease Patients Aimed at Identifying Intestinal Microbial Profiles Correlated With Low and High Risk of Severe Disease Course

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06324591
• Other study ID #: RISKCROHNBIOM
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
Austria	Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine	Graz
Italy	Ospedale Maggiore-Azienda Usl Di Bologna	Bologna
Italy	Meyer Children's Hospital IRCCS	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Countries where clinical trial is conducted

Austria,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	3 years after beginning of the study
Secondary	Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk	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
Secondary	Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification	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	3 years after beginning of the study