Bologna IBD Markers

Nestlé

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02580864

13.27.NIHS

Details and patient eligibility

About

Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 Exclusion criteria for no-IBD controls:

• Medical history of digestive diseases
• Digestive, renal or metabolic disease, as determined by the medical visit and sa blood chemistry analysis

Trial design

84 participants in 2 patient groups

IBD patients

Description:

120 adult patients (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease (220≤ CDAI ≤450; blood CRP ≥5 mg/L and/or fecal calprotectin ≥250mg/L) and with indication for anti-TNF therapy according to the normal clinical practice

No-IBD patients

Description:

30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic