Irritable Bowel Syndrome (IBS)
Conditions
Interventions
4-week intervention period with five parallel arms: 1) Chondroitin sulfate, 2)
NOVELOSE® 3490, 3) Pea Fiber, 4) Lactium®, and 5) Placebo supplement
(Maltodextrin control), during which the study par
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - IBS patients that meet the Rome IV criteria. This will be evaluated by the medical supervisor; - Male and female adults, aged 18-65 years; - Having a Body Mass Index (BMI) between 18.5 and 30 kg/m2; - Willing to keep a stable dietary pattern throughout the study; - Having a smartphone to fill out the daily questionnaires;
Exclusion criteria
Exclusion criteria: - Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease, or Ulcerative colitis; - Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy; - Having a food allergy to milk protein or pulse protein; - Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease; - When applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and wellbeing; - Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study; - Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements. Some supplements are allowed, but intake should be kept stable during the whole study period (Supplements will be judged by the medical supervisor MD Ben Witteman); - Currently following a FODMAP-restricted diet; - Use of medication that can interfere with the study outcomes, including anxiolytics (antidepressants are allowed), laxatives (Over-the-counter laxatives are allowed, but intake should be either stopped at least 4 weeks before the start of the study or kept stable during the complete study period), and codeine, as judged by the medical supervisor MD Ben Witteman; - Participation in another clinical trial at the same time; - Student or employee working at Food, Health and Consumer Research from Wageningen Food and Biobased Research; - Alcohol intake * 2 (women) or * 4 (men) glasses of alcoholic beverages per day; Abuse of illicit drugs - being incapacitated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the (relative) abundance of fecal Bifidobacterium. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are fecal microbiota composition, fecal SCFAs, stool frequency and consistency, IBS-related complaints, and Quality of Life. | — |
Countries
Netherlands
Outcome results
None listed