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

Targeting Gut Disease S.R.L.

Status

Terminated

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: BIOintestil

Dietary Supplement: PLACEBO

Study type

Interventional

Funder types

Industry

Identifiers

NCT04340661

TGD-01

Details and patient eligibility

About

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 Syndrome (IBS).

Full 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 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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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