Diet Habit, Microbial Colonization, Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, Diet, Microbiota, Emulsifying agent
Brief summary
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
OTHERNormal diet
These patients will be given advice about a normal healthy diet.
DIETARY_SUPPLEMENTE400 elimination
Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Although the patients know that they will be given dietary advice they will not know what type of intervention the other group will be offered. Since dietary advice must be given by the investigators the study cannot be blinded to them.
Intervention model description
Prospective randomized intervention study with elimination of putatively harmful substances in the diet
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calprotectin | One month | A protein in faeces that increases when there is a flare of the colitis |
| Microbiota diversity | One month | The diversity of the GI microbiota reflects disease severity |
Countries
Sweden
Contacts
Primary ContactKlas Sjöberg, Prof
Backup ContactSanna Davidson, MD
Outcome results
None listed