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

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).

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: BIOintestil; Dietary supplement: PLACEBO

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 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Chiara Valerii, PhD; Phone Number: +393284258960; Email: chiaravalerri@hotmail.it
• Study Contact Backup: Name: Enzo Spisni, PhD; Email: enzo.spisni@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • A.O.U Policlinico S.Orsola-Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo arm	Dietary supplement: PLACEBO; Cornstarch
Experimental: Bionocol arm	Dietary supplement: BIOintestil; Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii); Other Names: BIONOCOL

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Targeting Gut Disease S.R.L.
• Investigators: Principal Investigator: Fernando Rizzello, MD, A.O.U Policlinico S.Orsola-Malpighi

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Microbiota; immune system
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: TGD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No