NCT07857447Not yet recruiting
The Effects of a Modified Mediterranean Diet on Ulcerative Colitis Patients
Galectin-3, Fecal Calprotectin and Intestinal Ultrasound for Assessing the Effects of a Modified Mediterranean Diet on Ulcerative Colitis Disease Activity
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 13 Jul 2025
- Start date
- Oct 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Diseases
- Ulcerative colitis
- NCT number
- NCT07857447
What you commit to
- Study type: Interventional
- Planned participants: 62
- From Oct 2026 to the primary completion date, Dec 2027
- 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
- Previous major resections of digestive tract organs
Other illness
- Diabetes mellitus
- Crohn's disease
- Other severe systemic or malignant disease
- Clinical eating disorder
- Irritable bowel syndrome
Other
- Current use of enteral nutritional preparations
- Antibiotic use within 14 days
- Severe acute colitis
- Pregnancy
- Dysphagia
- Digestive tract obstruction
- BMI \< 16
- Avoidance of foods of animal origin (veganism)
- Isolated proctitis
Who the study is looking for
- 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).
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 |
|---|---|---|---|
| University Hospital Center Sestre milosrdnice Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.