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.
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).
Current use of enteral nutritional preparations
Antibiotic use within 14 days
Severe acute colitis
Diabetes mellitus
Parallel
Modified Mediterranean Diet
Other interventionA Modified Mediterranean Diet with reduced carbohydrate content and preserved fibre content will be used in the primary intervention group. The participants randomized to this group will receive a weekly meal plan based on personalized nutritional assessment.
Standard Nutritional Guidance
Other interventionThe comparator arm will receive standard nutritional guidance on the importance of a diverse diet and avoiding vitamin and mineral deficiencies.
Percentage of Participants Achieving Clinical Remission per Simple Clinical Colitis Activity Index (SCCAI) at Week 12
The percentage of participants achieving clinical remission as defined by SCCAI \<=2
Mean change of serum levels of Galectin-3 in study participants
Measuring Galectin-3 levels in the serum of participants at Baseline and Week 12 to assess correlation with disease activity
Percentage of Participants Achieving Intestinal Ultrasound Remission at Week 12
The percentage of participants achieving Intestinal ultrasound remission defined as bowel wall thickness \<3 mm and color doppler signal = 0
Percentage of Participants Achieving Fecal Calprotectin Levels <50 mg/kg at Week 12
Fecal calprotectin will be measured in stool samples of participants at baseline and Week 12. The percentage of patients achieving fecal calprotectin \<50 mg/kg measured at Week 12 will be reported.
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The mean change from baseline in IBDQ score will be presented.
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
The FACIT-Fatigue assesses self-reported fatigue and its impact upon daily activities and function. The mean change from baseline in FACIT-Fatigue score will be presented.
Exploratory Digital Biomarkers
Scanning the Tongue, Oral Cavity, and Other Facial Biomarkers: This involves using a smartphone camera and a multispectral device to analyze parameters like color, texture, glossitis, and other changes in the oral cavity and the rest of the face. These changes can be linked to inflammation or general health status. The technology allows for the detection of subtle changes in real-time, which can improve disease monitoring.
Exploratory multiomics - microbiological, genetic, and epigenetic analyses of blood, stool and oral swab samples.
Collection of Biological Samples: Blood - taking samples for the analysis of biomarkers related to inflammation and immune functions, as well as genetic and epigenetic analyses. Stool - collecting samples for microbiological, genetic, and epigenetic analyses. Oral swab sample - collecting oral swab samples for microbiological, genetic, and epigenetic analyses.
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