Ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
Carrageenan 2-2.5 g/day vs oat fiber, corresponding dose
The study starts with a 7-day run-in period (low carrageenan diet, instructed by a dietician), then either a carrageenan period or an oat fibe
Sponsors
Juhani Aho Medical Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ulcerative colitis, clinical remission verified by normal fecal calprotectin 2. Aged 18-64 years 3. No biological medications or systemic cortisone usage for relapse
Exclusion criteria
Exclusion criteria: 1. Pregnancy/lactation 2. Currently participating in another clinical intervention study 3. Intestinal surgery 4. Cancer 5. Other severe illness which might affect the patient's ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colitis activity measured using the Simple Clinical Colitis Assessment Index (SCCAI) at baseline and the 7th day of both treatment periods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal symptoms measured by Visual Analog Scale (VAS) 0-100 at baseline and the 1st, 3rd and 7th day of both treatment periods at the end of the each day 2. Laboratory tests using blood, urine and stool samples at baseline and at the end (7th day) of both treatment periods: 2.1. Fecal calprotectin 2.2. hs-CRP 2.3. S-FABP-2 (intestinal permeability marker) 2.4. U-creatinine 2.5. U-Albumin 2.6. F-albumin 2.7. F-IgG 2.8. F-intestinal alkaline phosphatase (IAP) 3. Macronutrient and fiber intake measured using a food diary at the end of both treatment periods covering days 5, 6 and 7 (i.e. a 3-day food diary) | — |
Countries
Finland
Outcome results
None listed