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OpenTrials
Completed

NCT Number: NCT05253378

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laurent PEYRIN-BIROULET, Vandœuvre-lès-Nancy, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Subject unable to comply with study procedures
  • Surgery for CD 3 months prior to inclusion visit

Treatment and study plan

Primary outcomes

  1. To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

    Time frame: Through study completion, an average of 3 years

    Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: NEMO-Index

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2022
Registry last updated
May 6, 2025

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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