Irritable bowel syndrome Digestive System Irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged between 18 and 65 years 3. Irritable bowel syndrome (Rome III criteria)
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Regular smoking 3. Implanted electrical device (e.g. artificial cardiac pacemaker) 4. Significant abdominal surgery (e.g. bowel resection) 5. Celiac disease 6. Crohn’s disease 7. Diverticulitis 8. Dyspepsia 9. Dysphagia 10. Stomach bezoar 11. Suspicion of intestinal stenosis 12. Difficult constipation or medication that affects intestinal motility 13. Hormonal, renal, blood or liver disease 14. Participation in other clinical trial in less 2 months before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal symptoms are measured using a visual analogue scale (VAS) questionnaire every half an hour for 12 hours and then every three hours until the wireless motility capsule (WMC) is defecated 2. Hydrogen production is measured using a hydrogen breath test device (Gastrolyzer®, Bedfont Scientific, UK) every half an hour for 12 hours and then every three hours until the WMC is defecated 3. Gastrointestinal pH is measured using the wireless motility capsule (SmartPill®, Given Imaging, GA, USA) during the whole test period 4. Gastrointestinal pressure is measured continuously using the wireless motility capsule (SmartPill®) during the whole test period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal temperature is measured continuously using the wireless motility capsule (SmartPill®) during the whole test period (until the WMC is defecated) 2. Transit time is measured continuously using the wireless motility capsule (SmartPill®) during the whole test period (until the WMC is defecated) | — |
Countries
Finland