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OpenTrials
Completed

NCT Number: NCT02580864

Bologna IBD Markers

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bologna University

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of IBD patients in clinical remission at 12 months

    Time frame: 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 outcomes

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

    Time frame: 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
  2. Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects

    Time frame: 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
  3. Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management

    Time frame: Baseline

    • Through analysis of gut microbiota composition
    • Through clinical nutritional status

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Predictive Factors of Anti-TNFalfa-induced Deep Remission in Crohn's Disease

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 20, 2015
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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