Irritable bowel syndrome (IBS) Digestive System Irritable bowel syndrome (IBS)
Conditions
Interventions
Participants underwent geraniol treatment for a period of 4 weeks and was taken daily at a maximum dose of 8 mg/Kg/day. Geraniol was provided in capsules containing 150 mg geraniol and 160 mg soy leci
Sponsors
University of Bologna
Xeda international
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signature of informed consent 2) Irritable bowel syndrome, meeting the Roma III criteria for diagnosis of IBS 3) Body weight between 46 kg and 100 kg, with BMI less than 27 4) Aged 18-65 years
Exclusion criteria
Exclusion criteria: 1. Taken steroid anti-inflammatory drugs, antibiotics or supplements and/or functional foods containing probiotics or prebiotics in the months prior to enrolment 2. Pregnancy, suspected pregnancy or breastfeeding 3. Diagnosed with IBD 4. Coeliac disease 5. Severe systemic disease 6. Lactose intolerant 7. Known food allergies 8. Known or suspected hypersensitivity to geraniol or soy 9. Serious concomitant diseases that contraindicate participation in the study (in the opinion of the investigator) 10. Use of experimental drugs in the 2 months prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in fecal microbiota composition after 4 weeks of geraniol administration was measured through phylogenetic DNA array analysis of fecal samples before starting geraniol treatment (visit 1), after 4 weeks of treatment (visit 2) and 4 weeks after treatment finished (visit 3, after 4 weeks of wash out). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fecal microbial composition in patients with IBS was measured using phylogenetic DNA array analysis of fecal samples before starting geraniol treatment (visit 1). 2. Changes in the microbiota-immune system axis was measured through Luminex analysis of plasma for the levels of cytokines and chemokines involved in the T helper 17 pathway (IL-1ß, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, IFN-?, sCD40L, TNF-a). This was measured before starting geraniol treatment (visit 1), after 4 weeks of treatment (visit 2) and 4 weeks after treatment finished (visit 3). | — |
Countries
Italy
Outcome results
None listed