gut complaints without medical diagnoses
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 the gut comfort component score at day 21 of the study (component score is based on 5 questions: bloating, flatulence, stomach ache, constipation and diarrhea in the past 7 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Component (summed) score of gut comfort after 4 and 14 days. - Shifts in microbial composition (through 16s sequencing) after 21 days | — |
Contacts
FrieslandCampina