Irritable bowel syndrome associated constipation (IBS-C) Digestive System Irritable bowel syndrome associated constipation (IBS-C)
Conditions
Interventions
For the study 150 adult subjects, diagnosed with irritable bowel syndrome associated to constipation (IBS-C) were enrolled and divided in three groups (F_1, F_2, F_3). Each group received a daily oral
during this period they doesn’t take anything.
Sponsors
Farcoderm S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years old 2. Suffering from Irritable Bowel Syndrome with constipation (IBS-C)
Exclusion criteria
Exclusion criteria: 1. Pregnancy or intention to become pregnant during the study period 2. Lactation 3. Food intolerances/allergy 4. Known history of gastro-intestinal disorders 5. Chronic or acute gastrointestinal disorders 6. Participation in another similar study 7. Unwillingness or inability to comply with the study protocol requirements 8. Currently using food supplements or drugs containing actives having an influence on gastro-intestinal physiology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. IBS-C symptoms are measured using the IBS-C questionnaire of related symptoms, which consists of five items (bloating, abdominal pain, constipation, abdominal cramps and flatulence) scored on a 10-point Visual Analogue Scale (VAS) at baseline, 10, 30 and 60 days 2. Gut colonization is determined through fecal microbiological analyses using species-specific qPCR on stool samples collected at baseline, 10, 30 and 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of the obtained effects are measured using IBS-C symptoms questionnaire microbiological analyses performed by species-specific qPCR 30 days after the last product(s) intake. | — |
Countries
Italy
Outcome results
None listed