Micronutrient and Additive Modifications May Optimize Diet To Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ulcerative colitis,
Moderately active
Stable medication
Disqualifiers
Severe disease
Recent surgery
Proctitis
Pregancy
Trial design
Design model
Parallel
Treatments tested in this trial
Normal diet
Other interventionThese patients will be given advice about a normal healthy diet.
E400 elimination
Dietary supplementPatients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Normal dietOther 1 intervention
Group B: E400 eliminationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Calprotectin
A protein in faeces that increases when there is a flare of the colitis
Time frame
One month2
Microbiota diversity
The diversity of the GI microbiota reflects disease severity
Time frame
One monthSponsors and contacts
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Source ClinicalTrials.gov