UCNot yet recruiting
The Effects of a Modified Mediterranean Diet on Ulcerative Colitis Patients
Not applicable · Testing Modified Mediterranean Diet and Standard Nutritional Guidance · 1 site · University Hospital Sestre Milosrdnice
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Modified Mediterranean Diet and Standard Nutritional Guidance as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)…
- 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…
There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 62 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-10 (planned).
- Main results expected around 2027-12 (estimate from the record).
- 1 study site listed in Croatia.
Groups in this study
- Modified Mediterranean Diet Arm (listed as: active comparator group)
- Standard Nutritional Guidance Arm (listed as: active comparator group)
Main thing being measured
- Percentage of Participants Achieving Clinical Remission per Simple Clinical Colitis Activity Index (SCCAI) at Week 12 (Week 12)
- Mean change of serum levels of Galectin-3 in study participants (Baseline and Week 12)
In the researchers’ words
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,…
Words you might see
- Randomized: participants are put into groups by chance, like a coin flip.
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Endoscopy: a camera exam inside the digestive tract.
- Remission: a period when the disease is quiet or under control.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | University Hospital Sestre Milosrdnice |
| Enrollment | 62 (estimated) |
| Start date | 2026-10 |
| Primary completion (est.) | 2027-12 |
| First posted | 2026-10-05 |
| Last updated | 2026-10-05 |
| Official title | Galectin-3, Fecal Calprotectin and Intestinal Ultrasound for Assessing the Effects of a Modified Mediterranean Diet on Ulcerative Colitis Disease Activity |
| ClinicalTrials.gov ID | NCT07857447 |
Interventions
- Modified Mediterranean Diet (Other)
A 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)
The comparator arm will receive standard nutritional guidance on the importance of a diverse diet and avoiding vitamin and mineral deficiencies.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Center Sestre milosrdnice | Zagreb | Croatia |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.