gut complaints
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Female - 25 - 45 years of age - Component (summed) score for gut complaints * 6 (based on bloating, flatulence, stomach ache, constipation, diarrhea)
Exclusion criteria
Exclusion criteria: - Any medical diagnosed disease underlying gut-related complaints, including Irritable Bowel Syndrome, celiac disease, Crohn*s disease, colitis, haemorrhoids, cancer, and/or any other disease considered relevant as determined during screening. - Use of antibiotics, opiates, anti-inflammatory drugs (NSAIDs) and/or metformin, and/or other medication that are known to affect the composition of the gut microbiota during the 14 days before inclusion. - Pregnant or lactating. - Self-reported lactose intolerance - Self-reported cow*s milk protein allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is a component score of gut comfort feelings based on 5 questions regarding bloating, flatulence, stomach ache, constipation and diarrhea of the past 7 days (each answer ranging from 0 -3; thus component score can range from 0-15). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to assess the effects of GOS on the component score of gut comfort at days 4 and 14 and the shifts in microbial composition after 21 days. | — |
Countries
Netherlands