Bologna IBD Markers

NCT02580864 | Completed

• 1 other identifier: 13.27.NIHS
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Number of IBD patients in clinical remission at 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

  12 months

Secondary Outcomes (3)

• Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months

  Baseline vs Baseline + 12 months

• Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects

  Baseline vs Baseline + 12 months

• Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management

  Baseline

Study Arms (2)

IBD patients

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

120 adult patients with moderate-severe active Crohns disease with indication for anti-TNF therapy according to the normal clinical practice 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Bologna University

Bologna, 40138, Italy

Location

Related Publications (1)

• Rizzello F, Gionchetti P, Spisni E, Saracino IM, Bellocchio I, Spigarelli R, Collini N, Imbesi V, Dervieux T, Alvisi P, Valerii MC. Dietary Habits and Nutrient Deficiencies in a Cohort of European Crohn's Disease Adult Patients. Int J Mol Sci. 2023 Jan 12;24(2):1494. doi: 10.3390/ijms24021494.

  PMID: 36675009 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, biopsy and urine

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

IT (1)