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Not Yet Recruiting NCT05743153

Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis

Conditions: Ulcerative Colitis Flare, Ulcerative Colitis

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: Radboud University Medical Center

Location: Netherlands

Summary

This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients starting new medical UC treatment. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.

Eligibility Criteria

Inclusion Criteria:Age ≥ 18 years old;Diagnosis of UC confirmed by clinical, endoscopic, and/or histological evidence prior to screening as per standard criteria;Moderately to severely active UC defined by a Simple Clinical Colitis Activity Index (SCCAI) > 2 and biochemical parameters (C-reactive protein > 5 and/or fecal calprotectin > 200) or physician judgement, currently non-responsive to their existing treatment and requiring a change of treatment;Ability of subject to participate fully in all aspects of this project;Written informed consent must be obtained and documented.Exclusion Criteria:Suspicion of differential diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis;Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures;History of psychiatric disorders that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures;If female, the subject is pregnant or lactating or intending to become pregnant;Immobilized patients who are not able to complete exercise intervention;Illiteracy (disability to read and understand Dutch).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05743153). StuddyBuddy aggregates publicly available trial information.