irritable bowel syndrome spastic colon
Conditions
Interventions
Participants will receive a daily dose of citrus extract or placebo for a
period of 8 weeks. Two capsules of citrus extract or placebo have to be
ingested every day before the first meal with a glas
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with IBS, Calprotectin levels 15-150 µg/g feces, Age 18-70 years, BMI
Exclusion criteria
Exclusion criteria: * Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator) * Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator) * Use of immunosuppressive drugs within 3 months before study period * Use of other medication interfering with endpoints * Changes in medication that may significantly affect the study outcome according to the investigator*s judgment within 1 month prior to the study * Changes in clinical activity scores within 3 weeks prior to the study * Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study * Use of dietary supplements containing antioxidants, minerals and vitamins * Excessive intake of foods with a high polyphenol concentration * Use of antibiotics within 3 months prior to the start of study * Use of pre-or probiotics within 1 month prior to the study * Use of oral corticosteroids within 1 month prior to the study * Blood donation within 1 month prior to the study * Known pregnancy or lactation. * Excessive drinking (>20 alcoholic consumptions per week) * History of any side effects towards the intake of flavonoids or citrus fruits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the evaluation of intestinal inflammation, measured by levels of fecal calprotectin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints entail the evaluation of daily administration of citrus extract on metabolic activity (fecal markers), microbiota composition and functional capacity (fecal markers), immune system performance (blood markers), gastrointestinal symptoms (questionnaires), and oxidative stress markers (blood markers). | — |
Countries
Netherlands
Outcome results
None listed