Actively Recruiting
Micronutrient and Additive Modifications May Optimize Diet To Health for Moderately Active Ulcerative Colitis
Led by Region Skane · Updated on 2026-01-12
70
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dietary changes on patients with moderately active ulcerative colitis. This prospective clinical trial compares a normal healthy diet to a diet that eliminates specific emulsifying agents, particularly carrageenan, CMC, and polysorbates, which are part of the E 400 additive group. The goal is to see if removing these additives can improve disease activity and the gut microbiota. Participants are randomly assigned to one of two groups: one group receives standard dietary advice for ulcerative colitis, while the other group receives advice to eliminate E400 additives from their diet. Diets are recorded at the beginning and after one month using a food diary and a food frequency questionnaire focused on E400 intake. Clinical characteristics, disease activity markers like diarrhea frequency, blood in stools, abdominal pain, CRP, calprotectin, and microbiota samples are collected and analyzed. During the study, participants will have their diets and clinical status assessed at the start and after one month. Researchers will measure outcomes including calprotectin levels and microbiota diversity to evaluate disease activity and gut health. The study includes monitoring of clinical symptoms and microbiota composition using advanced sequencing methods. Participation involves diet recording and clinical assessments over a one-month period to track changes and safety.
CONDITIONS
Brief Title
Micronutrient and Additive Modifications May Optimize Diet To Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ulcerative colitis
- Moderately active disease
- Stable medication for ulcerative colitis
- Age 18 years or older
You will not qualify if you...
- Severe ulcerative colitis
- Recent surgery
- Proctitis
- Pregnancy
- Treatment with antibiotics
- Difficulty understanding study information
- Multiple health conditions preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants follow assigned dietary advice to either maintain a normal diet or eliminate E400 additives, with clinical characteristics and diet recorded at the start and end of the treatment period.
2 visits (in-person) including diet recording and clinical assessments
Trial Site Locations
Total: 1 location
1
Region Skåne
Malmö, Skåne County, Sweden, 21428
Actively Recruiting
Research Team
K
Klas Sjöberg, Prof
S
Sanna Davidson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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