Crohn's DiseaseNCT02580864
Bologna IBD Markers
An observational study of Crohn's Disease, run by Société des Produits Nestlé (SPN) at 1 site in Italy.
Trial summary
Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
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 locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors of Anti-TNFalfa-induced Deep Remission in Crohn's Disease
Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.
Read the 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.
- Conditions
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
Number of IBD patients requiring an escalation treatment to be 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
Measured: Baseline vs Baseline + 12 months
Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects
- 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
Measured: Baseline vs Baseline + 12 months
Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management
- Through analysis of gut microbiota composition
- Through clinical nutritional status
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580864
- Sponsor's protocol ID
- 13.27.NIHS
- Status last verified
- Jul 2019
- First submitted
- 16 Sep 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36675009
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Anti-TNFalfa-induced Deep Remission in Crohn's Disease
- ClinicalTrials.gov ID
- NCT02580864
- Acronym / sponsor ID
- 13.27.NIHS
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months
Time frame: Baseline vs Baseline + 12 months
Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects
Time frame: Baseline vs Baseline + 12 months
Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 36675009Rizzello 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.
Related trials for Crohn's Disease
Recruiting
A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Inflammatory Bowel Disease
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Not yet recruitingPhase 1
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
RecruitingPhase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis, Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Société des Produits Nestlé (SPN) at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of IBD patients in clinical remission at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.