Irritable Bowel Syndrome
Conditions
Interventions
A 4 week run-in period will be followed by a 4-week intervention period with
three parallel arms: 1) prebiotic supplement (Inavea pure acacia), 2) probiotic
supplement (B. lactis), and 3) Placebo su
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * IBS patients that meet the Rome IV criteria + additional criteria specific for the constipation-predominant subtype. * Male and female adults, aged 18-70 years. * Have a Body Mass Index (BMI) between 18.5 and 30 kg/m2 (self-reported). * 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 disease that may interfere with the outcomes of this study, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism. * History of intestinal surgery (excluding appendectomy or cholecystectomy) or endometriosis. * Use of medication that can interfere with the study outcomes, including antidepressants (allowed when it is not subscribed for mental depression), codeine, and antibiotics, as judged by the medical supervisor MD Ben Witteman. * Use of prescribed laxatives. Over-the-counter laxatives are allowed, but intake should be either stopped before the start of the study or kept stable during the complete study period. * Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements dedicated to bowel function improvements. 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). * If applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool pattern and wellbeing. * Participation in another clinical trial at the same time. * Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition & Health, Wageningen University. * Alcohol intake * 2 (women) or * 4 (men) glasses of alcoholic beverages per day. * Abuse of illicit drugs, soft drugs, and nitrous oxide. * Smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is stool pattern: stool frequency, stool consistency and stool volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are gastrointestinal complaints, Quality of Life, and HADS. | — |
Countries
Netherlands
Outcome results
None listed