chronic intestinal inflammation colon inflammation
Conditions
Interventions
An 8-week intervention period with four parallel arms: 1) predicted responders
with prebiotics treatment (acacia gum, partially hydrolyzed guar gum, and
resistant starch), 2) predicted responders wi
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 65 years 2. Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported) 3. Ulcerative Colitis confirmed via previous endoscopy and histology 4. Mild active UC as defined by Patient Simple Clinical Colitis Activity Index (P-SCCAI) score of 3 to 5 (range 0 to 19) 5. Frequent relapse (at least one exacerbation in the last two years) 6. No known allergy to any components of the study product (self-reported) 7. Signed informed consent 8. Stable UC medication defined as no switch to other medication or no dose change 9. mobile phone on which apps (used for questionnaires) can be downloaded (iOS version 9 and newer, Android version 4.4 and newer. Phones manufactured after 2013 are usually suitable) 10. stable dietary pattern during the study
Exclusion criteria
Exclusion criteria: 1. Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy 2. Pregnancy or intending to become pregnant during the study 3. Use of medication that can interfere with the study outcomes, as judged by the medical supervisor 4. The need for antibiotic use during the study period 5. Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameter is a difference in response (mean P-SCCAI score) between arms at T = 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters are, response over time (at T = 0, 4, 8, 12, and 60 weeksP-SCCAI score), mucosal inflammation (fecal calprotectin), gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, health-related quality of life, medication use, and safety parameters. | — |
Countries
Netherlands
Outcome results
None listed