NCT07167186Not yet recruiting
Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Inflammatory bowel diseases (IBD) are long-term conditions affecting more than 250,000 people in France. They typically begin in young adults and are characterized by flare-ups interspersed with periods of remission. The impact of these diseases goes beyond digestive symptoms, with fatigue present in 50 to 80% of cases. The overall effect on health leads to a decline in quality of life and work productivity. Therapeutic management relies on long-term immunosuppressive treatments aimed at inducing prolonged remission. While therapeutic management has become more complex with an increasing number of available treatments, evaluating the effectiveness and tolerance of these treatments requires a multimodal approach, including therapeutic education and specific follow-up based on the patient's profile and treatment, with the goal of comprehensive care and precision medicine. Recently, multimodal day hospitalizations have been developed, particularly in response to the recent evolution of treatment administration routes toward subcutaneous or oral forms. In 2022, the gastroenterology and nutrition department of Saint Antoine Hospital, which follows 3,500 patients with CIBD, created a multimodal day hospital (DH) (four interventions) dedicated to patients treated with biologics and Janus kinase inhibitors. In a single session, this approach systematically combines (1) specific biological tests, especially pharmacokinetics, (2) a consultation with a gastroenterologist, (3) a consultation with a therapeutic education nurse, (4) and, depending on the identified needs of the patients, a dietary workshop or fatigue management session; a specialized dermatology or rheumatology consultation; and an ultrasound of the intestinal wall. The goal of this study is to assess the benefits of a multimodal day hospital on the management and skills of patients with IBD.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- Sept 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07167186
What you commit to
- Study type: Observational
- Planned participants: 240
- From Sept 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who has previously participated in an equivalent day hospital program.
Other
- Protective measure in place.
- Pregnant woman.
Who the study is looking for
- Patient diagnosed with ulcerative colitis and Crohn's disease for more than 3 months, with a confirmed diagnosis according to European guidelines, being followed in the gastroenterology department at Saint Antoine Hospital.
- Aged over 18 years.
- Undergoing a multimodal day hospital visit, regardless of the scheduled intervention in the gastroenterology department at Saint Antoine Hospital.
- Not opposed to participating in the research.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de gastroentérologie Hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.