Micronutrient and Additive Modifications May Optimize Diet To Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal diet, E400 elimination.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Diet Habit, Microbial Colonization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Patients with ulcerative colitis attending the out-patient clinic at Skåne university hospital with calprotectin 100-600 will be invited to participate in this diet intervention study. They will be divided into two arms with 35 patients in each, normal diet or E-400 elimination. The diet will be recorded at study start and end with a food diary for four days and a food frequency questionnaire regarding E-400 intake. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded and microbiota collectted. The hypotheses are that the activity measured with clinical characteristics and calprotectin as well as their microboita measured with dysbiosis index and total genom with NGS will improve significantly.
Interventions
- Other Normal diet
These patients will be given advice about a normal healthy diet. - Dietary supplement E400 elimination
Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.
Primary outcome measures
- Calprotectin [Time frame: One month]
- Microbiota diversity [Time frame: One month]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Sweden · 1 center
- Region Skåne — Malmö
Identifiers
NCT: NCT05743374 · 2022-01347