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

NCT06324591 | Active Not Recruiting

• 1 other identifier: RISKCROHNBIOM
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  3 years after beginning of the study

Study Arms (1)

patient with Chron's Disease

OTHER

Only patient with Crohn's Disease

Other: Collection biological sample and analysis

Interventions

Collection biological sample and analysis 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

patient with Chron's Disease

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Refusal to participate in the study.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (3)

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

Graz, Austria

Location

Ospedale Maggiore-Azienda Usl Di Bologna

Bologna, Italy

Location

Meyer Children's Hospital IRCCS

Florence, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Paolo Lionetti

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 22, 2024
• Study Start: February 3, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

IT (2); AU (1)