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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55240
Enrollment
185
Registered
2020-09-17
Start date
2020-10-28
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)