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

Primary Purpose

Irritable Bowel Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

BIOintestil

PLACEBO

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Microbiota, immune system

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

A.O.U Policlinico S.Orsola-Malpighi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bionocol arm

Placebo arm

Arm Description

Outcomes

Primary Outcome Measures

Changes in fecal Microbiota composition

relative abundance of bacteroidetes

Secondary Outcome Measures

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

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").

Full Information

NCT ID

NCT04340661

First Posted

September 3, 2019

Last Updated

April 13, 2023

Sponsor

Targeting Gut Disease S.R.L.

1. Study Identification

Unique Protocol Identification Number

NCT04340661

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor Decision

Study Start Date

December 5, 2018 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Targeting Gut Disease S.R.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 Syndrome (IBS).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Microbiota, immune system

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bionocol arm

Arm Type

Experimental

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

BIOintestil

Other Intervention Name(s)

BIONOCOL

Intervention Description

Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)

Intervention Type

Dietary Supplement

Intervention Name(s)

PLACEBO

Intervention Description

Cornstarch

Primary Outcome Measure Information:

Title

Changes in fecal Microbiota composition

Description

relative abundance of bacteroidetes

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Changes in circulating cytokines and chemokines

Description

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

Time Frame

4 weeks

Title

Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Rizzello, MD

Organizational Affiliation

A.O.U Policlinico S.Orsola-Malpighi

Official's Role

Principal Investigator

Facility Information:

Facility Name

A.O.U Policlinico S.Orsola-Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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