Status:
TERMINATED
Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients
Lead Sponsor:
Targeting Gut Disease S.R.L.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrom...
Detailed Description
BIOintestil is a dietary supplement based on Palmrose oil (Cymbopogon martinii) and ginger ryzoma powder. Palmrose oil effects were already established in animal model of colitis and in a pilot study ...
Eligibility Criteria
Inclusion
- willing of sign written informed consent;
- participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis
- body weight between 48 and 104 kg, with a BMI less than 27
- age between 18 and 65 years old
Exclusion
- participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics
- women who suspect to be/are pregnant or in lactacy
- participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease
- participants who are intolerant to lactose or with food allergies confirmed
- particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components
- participants with severe concomitants disease that, by investigator's opinion, interfere with study partecipation
- participants under anticoagulant therapy or with coagulation disease
- participants with renal and hepatic failure
- participants who have taken any investigational drug within 2 month the randomization visit
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04340661
Start Date
December 5 2018
End Date
January 31 2021
Last Update
April 18 2023
Active Locations (1)
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1
A.O.U Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138