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Not Yet Recruiting NCT07857447

The Effects of a Modified Mediterranean Diet on Ulcerative Colitis Patients

Conditions: Ulcerative Colitis (UC)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 62
Sponsor: University Hospital Sestre Milosrdnice

Location: University Hospital Center Sestre milosrdnice Zagreb

Summary

Ulcerative colitis is a chronic disease with a significant impact on quality of life where a substantial proportion of patients fails to achieve disease remission. It is a multifactorial disease, and the influence of diet on its onset and course remains underexplored. Favorable effects of the Mediterranean diet on numerous diseases have been confirmed in clinical research, but in the case of ulcerative colitis, there is a lack of well-designed studies. The aim of this study is to demonstrate that a modified Mediterranean diet (MMD) with reduced carbohydrate intake over a duration of 12 weeks, in conjunction with standard therapy, has a favorable impact on symptoms and objective markers of inflammation in ulcerative colitis patients. A prospective randomized study will involve participants divided into a control and an intervention group. Over the course of 12 weeks, they will adhere to MMD under nutritionist guidance or follow standard dietary recommendations.

Eligibility Criteria

Inclusion Criteria: * Adult patients (\>18 years of age) * Endoscopically confirmed ulcerative colitis within 16 weeks prior to inclusion Clinically, by biomarkers, and/or by ultrasound, active mild to moderate disease (within 14 days) defined as: 1) SCCAI (Simple Clinical Colitis Activity Index) 3-9 and 2)Calprotectin ≥150 mg/kg and/or 4)Ultrasound colon wall thickness ≥3 mm or ≥2.5 mm with presence of Doppler signal in the wall (within 14 days) * Stable dose of immunosuppressants, small molecules, or aminosalicylates for the past 4 weeks or Stable use of biological therapy for the past 16 weeks or Currently taking oral glucocorticoids at a dose up to 20 mg methylprednisolone (equivalent to 25 mg prednisone) with mandatory dose reduction after inclusion in the study (reduction of 4 mg methylprednisolone every 7 days or equivalent). Exclusion Criteria: * Current use of enteral nutritional preparations * Antibiotic use within 14 days * Severe acute colitis * Diabetes mellitus * Crohn's disease * Pregnancy * Previous major resections of digestive tract organs * Dysphagia * Digestive tract obstruction * Other severe systemic or malignant disease * Clinical eating disorder * BMI \< 16 * Avoidance of foods of animal origin (veganism) * Irritable bowel syndrome * Isolated proctitis

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07857447). StuddyBuddy aggregates publicly available trial information.