Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)

NCT05733702 | Recruiting

• 1 other identifier: LUX-CLIN-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of the Clinnova program. This is a prospective cohort study including patients with IBD recruited at the time of a treatment change. At least 800 participants (recruited in France, Germany and Luxembourg) will be enrolled, of which 100 participants are expected to be recruited in Luxembourg with the present study protocol. The mission of Clinnova is to support the digitalization of healthcare and precision medicine by creating a data-enabling environment for accessing, sharing and analyzing interoperable, high-quality health data. The main hypothesis is that treatment change decided by clinicians is predictable using objective surrogate markers derived from clinical, epidemiological, and omics data. Identifying these objective markers may facilitate future treatment decisions, provide new insights on the molecular causes for differential treatment response, pathogenesis and progression, and potential pointers for improved personalized therapeutic interventions.

Conditions

Inflammatory Bowel Diseases

Keywords

Artificial Intelligence; Personalized medicine; Treatment change; Phenotyping

Outcome Measures

Primary Outcomes (1)

• Identify clinical, epidemiological and omics characteristics associated with IBD activity triggering a treatment change in patients with UC or CD and allow the phenotyping of patients with similar characteristics

  The main hypothesis is that treatment change decided by clinicians is predictable using objective surrogate markers derived from clinical, epidemiological and omics data Identifying these objective markers may facilitate future treatment decisions, provide new insights on the molecular causes for differential treatment response, pathogenesis and progression, and potential pointers for improved personalized therapeutic interventions.

  2029

Secondary Outcomes (1)

• Identify clinical, epidemiological and omics characteristics associated with IBD individual patient outcome. Establish a sample and data bank to enable research on IBD. Develop applications for improved interaction between patients and medical doctors.

  2029

Study Arms (1)

Single arm study:

Patients with IBD requiring a treatment change at the time of inclusion

Other: All participants will be asked to provide data and samples for collection and analysis.

Interventions

All participants will be asked to provide data and samples for collection and analysis. OTHER

During the first year from the date of inclusion, data related to demographics, lifestyle, laboratory and physical examinations will be collected at baseline, at 3 months, and at 12 months. Patient-Reported Outcomes (PROs) with voice recordings will be collected at different time points in-between clinical visits using the Colive application. Participants will be asked to provide biological samples (i.e., blood, dried blood spots and stool are mandatory; saliva, urine and hair are optional), tissue samples from endoscopic biopsy and imaging data (if performed as per standard of care) at three timepoints (baseline; 3 months; 12 months). One unscheduled visit may be included in the study in case of occurrence of flare or treatment change.A long-term follow-up (starting from month 12 and up to 4 years after month 12) will include the collection of medical data on a yearly basis, collection of PROs with voice recording every 6 months and continuous collection of data using the smartwatch.

Single arm study:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult diagnosed with Inflammatory bowel disease (IBD), either Crohn's disease (CD) or ulcerative colitis (UC) who require a significant change in the treatment of the disease.

You may qualify if:

• ≥ 18 years old
• Participants are willing and able to comply with the protocol including undergoing data and sample collection as well as study visits and examinations.
• Signed informed consent form
• Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before the enrolment AND occurrence of a significant change in the treatment of the disease (either change of drug dosage OR change of medication within the same treatment class OR change of treatment class OR addition of a drug to a treatment regimen already ongoing). A change of drug dosage or frequency is considered significant if it fulfills the requirements in section 7.1 Note: Patients with ostomy or with short bowel syndrome can be included if they fulfill all the eligibility criteria

You may not qualify if:

• Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits (such as mental disability that makes it difficult or impossible to answer questionnaires)
• Not fluent in any of the following languages: French, English or German
• Known pregnancy

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Luxembourg National Research Fund: collaborator
• Centre Hospitalier du Luxembourg: collaborator
• Hôpitaux Robert Schuman: collaborator
• University of Luxembourg: collaborator

Study Sites (1)

Centre Hospitalier de Luxembourg (CHL)

Luxembourg, L-1210, Luxembourg

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine, saliva, hair, archiving tissue samples from Standard Of care biopsy

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Jasmin Schulz, PhD

CONTACT

+352 26970-265; Jasmin.Schulz@lih.lu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)