Functional gastrointestinal disorders including irritable bowel syndrome, functional dyspepsia/bloating and functional diarrhea Digestive System
Conditions
Interventions
Participants receive the 10-day intervention and 10-day control treatment in a random order, which are delivered at separate study visits (wash out at least 10 days apart). At baseline, participants
Sponsors
Valio Oyj Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years 2. Irritable bowel syndrome, functional dyspepsia/bloating and functional diarrhea (all defined by Rome IV criteria)
Exclusion criteria
Exclusion criteria: 1. Organic gastrointestinal disease such as Crohn's disease, ulcerative colitis, colorectal or gastric or any cancer 2. Pregnancy or breastfeeding 3. Significant abdominal surgery (e.g. bowel resection) 4. Difficult to treat constipation 5. Medication that affects intestinal motility and/or pain perception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal symptoms measured by IBS-SSS scoring system (Francis et al. 1997) at baseline and at the end of each treatment period 2. Abdominal pain, borgorygmia, intestinal gas and bloating evaluated on 4-point Likert scale daily | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Markers of immune activation/low-grade inflammation: e.g.IL-6, IL-1B and TNF-alfa from plasma using high-sensitivity ELISA kits and methylhistamine from overnight/12 h urine samples also using ELISA 2. Markers of intestinal permeability: FABP-2 from plasma using ELISA All biomarkers are measured at the beginning and the end of each 10-day treatment period | — |
Countries
Finland
Outcome results
None listed