It is aimed to develop fecal microbiota-metabolomics based algorithms for diagnostics, monitoring and predicting therapy response in IBD which can be applied in daily clinical practice and to identify predictive factors for outcome and treatment…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Not applicable.
Background summary
Inflammatory Bowel Disease (IBD) is a group of disorders of the
gastro-intestinal tract, characterized by chronic relapsing intestinal
inflammation. The gold standard to detect and monitor IBD is endoscopic
assessment which is costly and invasive, illustrating the need for development
of novel non-invasive diagnostic biomarkers. Previous studies have demonstrated
the potential of microbiota and intestinal metabolomics to serve as biomarkers
for monitoring disease activity and to predict therapy response in paediatric
IBD patients. However, these studies were characterized by a small sample size
and validation in larger cohort of paediatric IBD patients is needed.
Study objective
It is aimed to develop fecal microbiota-metabolomics based algorithms for
diagnostics, monitoring and predicting therapy response in IBD which can be
applied in daily clinical practice and to identify predictive factors for
outcome and treatment response or non-response.
Study design
The proposed study will be conducted in a prospective multicenter study design
with a longitudinal follow-up, starting mid-August 2020 for a duration of 36
months.
Study burden and risks
No blood sampling or endoscopy for this study will be performed outside routine
blood samplings and endoscopy. The patient*s risk of participation in this
proposed study is very low. Potential risks of a blood sample drawn are the
induction of temporary discomfort, bruising, swelling and/or in rare
circumstances, infection at the needle site. Potential risk of additional
biopsy taken from the digestive tract is the very small risk of a perforation
or bleeding (risk < 0.1%). Biopsies from the digestive tract will only be taken
during regular patient care endoscopic procedure involving biopsy taking.
The burden is considered minimal. Since disease phenotype, course of the
disease and benefits and risks of treatment differ between children and adults,
this study cannot be performed in adult patients.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74186.029.20 |