Optimizing diet for patients with ulcerative colitis
Micronutrient and Additive Modifications May Optimize Diet To Health
NA · Region Skane · NCT05743374
This study is testing if changing the diet by cutting out certain additives can help people with ulcerative colitis feel better and improve their gut health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane (other) |
| Locations | 1 site (Malmö, Skåne County) |
| Trial ID | NCT05743374 on ClinicalTrials.gov |
What this trial studies
This clinical intervention involves patients with moderately active ulcerative colitis who are randomized into two groups: one following a normal healthy diet and the other eliminating emulsifying agents such as carrageenan, CMC, and polysorbates. The study will analyze dietary habits, clinical characteristics, and microbiota before and after a one-month intervention. Key measurements will include disease activity assessed through calprotectin levels and microbiota diversity. The goal is to determine if dietary modifications can lead to improvements in disease symptoms and microbiota composition.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderately active ulcerative colitis who are on stable medication.
Not a fit: Patients with severe disease, recent surgery, or other complicating factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary approach to improve symptoms and microbiota health in patients with ulcerative colitis.
How similar studies have performed: While dietary interventions in ulcerative colitis have been explored, this specific approach focusing on emulsifying agents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ulcerative colitis, * Moderately active * Stable medication Exclusion Criteria: * Severe disease * Recent surgery * Proctitis * Pregancy * Treatment with antibiotics * Difficulties in understanding the information about the study * Multimorbidity that makes it impossible to participate
Where this trial is running
Malmö, Skåne County
- Region Skåne — Malmö, Skåne County, Sweden (RECRUITING)
Study contacts
- Principal investigator: Klas Sjöberg, Prof — Dept of Gastroenterology, SUS, Malmö, Sweden
- Study coordinator: Klas Sjöberg, Prof
- Email: klas.sjoberg@med.lu.se
- Phone: +46702372580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Diet Habit, Microbial Colonization, Ulcerative colitis, Diet, Microbiota, Emulsifying agent