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

NCT06324591 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Meyer Children's Hospital IRCCS

    lead OTHER

Principal Investigators

  • Paolo Lionetti · Meyer Children's Hospital IRCCS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Austria
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324591 on ClinicalTrials.gov