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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Collection biological sample and analysis

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patient with Chron's Disease; Only patient with Crohn's Disease	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS
• Investigators: Principal Investigator: Paolo Lionetti, Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: RISKCROHNBIOM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No