Crohn's Disease
Conditions
Brief summary
Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.
Detailed description
This trial will be exploratory, open in vitro study on human tissues. 120 patients will be enrolled (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease and with indication for anti-TNF therapy according to the normal clinical practice. Simultaneously, 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.
Interventions
None listed
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria for IBD patients: * Adult patients (Caucasian) * Moderate-severe active Crohns disease (220≤ CDAI ≤450; blood CRP ≥5 mg/L and/or fecal calprotectin ≥250mg/L) * Indication for anti-TNF therapy according to the normal clinical practice * Informed consent signed Main
Exclusion criteria
for IBD patients: * Changes of Crohns disease treatment gastrointestinal medication (including corticosteroids) within the previous 2 weeks prior to enrollment * Pregnant or breast-feeding (at index date) female patients Main Inclusion Criteria for no-IBD controls: * No-IBD adult controls (Caucasian) with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic * Informed consent signed Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of IBD patients in clinical remission at 12 months | 12 months | * Subjects without intestinal ulceration at endoscopy at 12 months * Subjects with CDAI score below 150 from baseline to 12 months * Subjects with blood CRP value below 0.8 mg/dL from baseline to 12 months * Subjects with stool calprotectin value below 50ug/g from baseline to 12 months * Through analysis of metabonomics on biopsies, blood, urine and stools * Through analysis of blood genotyping * Through analysis of gut microbiota composition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months | Baseline vs Baseline + 12 months | * Subjects without intestinal ulceration at endoscopy at 12 months * Subjects with CDAI score below 150 from baseline to 12 months * Subjects with blood CRP value below 0.8 mg/dL from baseline to 12 months * Subjects with stool calprotectin value below 50ug/g from baseline to 12 months * Through analysis of metabonomics on biopsies, blood, urine and stools * Through analysis of blood genotyping * Through analysis of gut microbiota composition |
| Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects | Baseline vs Baseline + 12 months | * Through analysis of metabonomics on blood, urine and stools * Through analysis of gut microbiota composition * Through clinical nutritional status in IBD patients compared to non-IBD subjects |
| Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management | Baseline | * Through analysis of gut microbiota composition * Through clinical nutritional status |
Countries
Italy
Outcome results
None listed