Irritable bowel syndrome Digestive System
Conditions
Interventions
This study is an interventional multicentre clinical trial, conducted open-label with the dietary supplement Eurekol™. Eurekol™ is a food supplement based on BIOintestil®, a mixture of Palmarosa (Cymb
Sponsors
Diadema Farmaceutici
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years 2. Signed informed consent 3. Diagnosis of IBS according to the Rome IV criteria 4. Body weight between 48 kg and 104 kg, with a BMI < 27
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to Palmarosa essential oil, Ginger or any excipients contained in the dietary supplement used for the treatment 2. Diagnosis of IBD, celiac disease or other severe systemic diseases 3. Severe concomitant diseases that, in the Investigator's opinion, contraindicate the patient's participation in the study 4. Lactose intolerance or confirmed food allergies 5. Use of steroidal anti-inflammatory drugs, antibiotics, or supplements and/or functional foods containing pre-/pro-biotics in the month preceding enrollment 6. Use of experimental drugs in the two months preceding enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the severity of IBS symptoms in the total population measured using the IBS-SSS questionnaire before and after 30 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in the severity of IBS symptoms in IBS subtype populations (IBS-C; IBS-D; IBS-M and IBS-U) measured using the IBS-SSS questionnaire before and after 30 days of treatment 2. Changes in bowel function measured using the Bristol Stool Chart before and after 30 days of treatment | — |
Countries
Italy
Contacts
Public ContactGiammario Piras
Outcome results
None listed