Micronutrient and Additive Modifications May Optimize Diet To Health
Recruiting · NCT05743374 · Interventional (participants receive a specific treatment) · Lead sponsor: Region Skane
View the official record on ClinicalTrials.gov →Interventions studied
E400 eliminationNormal diet
What this trial is about
This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Region Skåne - Malmö, Skåne County, Sweden