Faecal Metabolomics and Microbiota as Non-Invasive Biomarkers for Disease Activity and to Predict Treatment Response in Paediatric Inflammatory Bowel Disease

Completed

Conditions: Inflammatory bowel disease
10017969

Registration Number: NL-OMON55240

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 185

Inclusion Criteria

- Age of 4-17 years
- New patients with a suspicion of IBD or patients with gastrointestinal
symptoms who undergo diagnostic work-up (including clinical, laboratory and
faecal markers but not necessarily endoscopy) to exclude IBD may be recruited.
If a diagnosis is not confirmed after the investigations are complete they will
not be followed up any further but any specimens and clinical information can
be retained as controls
- Written informed consent
- Patients have not started IBD treatment yet

Exclusion Criteria

- Use of antibiotics or probiotics in the last 3 months prior to inclusion
- Use of immunosuppressive therapy prior to the study
- Patients diagnosed with immunocompromised disease (any of various diseases
that suppress the immune system)
- Inability to read and understand the patient and family information sheets
(for example insufficient knowledge of national language, where no health
advocate of family member is available to translate and ensure full
understanding of the study)
- Informed consent of patient and/or parents has not been obtained when
required

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We expect to identify IBD-specific microbial and metabolic profiles associated<br /><br>with disease activity, enabling development of clinical decision-making<br /><br>algorithms for earlier detection of paediatric IBD in an intention-to-diagnose<br /><br>population. This would allow for personalized and tailored monitoring of<br /><br>disease activity, timely recognition of exacerbations and prediction of<br /><br>treatment response, improving IBD care.</p><br>

Secondary Outcome Measures