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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05253378
Acronym
NEMO-Index
Enrollment
458
Registered
2022-02-23
Start date
2022-04-04
Completion date
2025-03-31
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Brief summary

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.

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.Through study completion, an average of 3 yearsProbability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).

Countries

France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026