Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients

Launched by TARGETING GUT DISEASE S.R.L. · Apr 7, 2020

Keywords

ClinConnect Summary

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 on patients with IBS. In this study, 108 patients will be randomized to receive BIOintestil or placebo in a 1:1 ratio, for four weeks. Fecal and blood samples will be collected at each visit for microbiota and chemokine analysis, patients syntoms will be evaluated by administration of the validated IBS-VAS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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