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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: BIOintestil
* Dietary Supplement: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bionocol arm<br> | Dietary Supplement: BIOintestil<br>* Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)<br>* Other names: BIONOCOL;|
| Placebo Comparator: Placebo arm<br> | Dietary Supplement: PLACEBO<br>* Cornstarch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fecal Microbiota composition | relative abundance of bacteroidetes | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in circulating cytokines and chemokines | IL-1β, IL-4, IL-6, IL-10,IL-17A,IL-17F, IL-21, IL-22, IL-23, IL-25, IL31, IL-33, IFN-γ, MIP-1b , MCP-1 cytokines and chemokines will be evaluated | 4 weeks | 
| Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement | Irritable Bowel Syndrome-Visual Analogue Scale is designed to measure the treatment response of symptoms and well-being in patients suffering from IBS. It is composed by 4 items: 1) abdominal pain, 2) Abnominal bloating, 3) Satisfaction of the intestinal habits 4) influence on daily life. The patients are asked to record in the VAS-IBS the overall severity of each of the 4 items on a 100-mm-long horizontal line (very severe discomfort 0 to no discomfort at all 100). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, immune system