Development and Validation of a Comorbidity Index in Crohn's Disease

Study Purpose

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 59 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients between 18 and 59 years old. 2. Established diagnosis of CD with a minimum disease duration of 3 months. 3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months.

Exclusion Criteria:

1. Subject unable to comply with study procedures. 2. Surgery for CD 3 months prior to inclusion visit

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05253378
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France, Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease

Contact a Trial Team

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International Sites

CHRU Nancy, Vandoeuvre-lès-Nancy, France

Status

Address

CHRU Nancy

Vandoeuvre-lès-Nancy, ,

Site Contact

Laurent Peyrin-Biroulet, MD, PhD

San Raffaele Hospital, Milano, Italy

Status

Address

San Raffaele Hospital

Milano, ,

Site Contact

Silvio Danese, MD, PhD

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