Micronutrient and Additive Modifications May Optimize Diet To Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Micronutrient and Additive Modifications May Optimize Diet To Health

Conditions
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Ulcerative Colitis, Diet Habit, Microbial Colonization

Intervention / Treatment
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* Other: Normal diet
* Dietary Supplement: E400 elimination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized intervention study with elimination of putatively harmful substances in the diet
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal diet<br>One arm will be given dietary advice that is always given to patients with ulcerative colitis. | Other: Normal diet<br>* These patients will be given advice about a normal healthy diet.<br>|
| Active Comparator: E400 elimination<br>The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates. | Dietary Supplement: E400 elimination<br>* Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calprotectin | A protein in faeces that increases when there is a flare of the colitis | One month | 
| Microbiota diversity | The diversity of the GI microbiota reflects disease severity | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, Diet, Microbiota, Emulsifying agent