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

NCT04340661 | Terminated DMC

• 1 other identifier: TGD-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome

Keywords

Microbiota; immune system

Outcome Measures

Primary Outcomes (1)

• Changes in fecal Microbiota composition

  relative abundance of bacteroidetes

  4 weeks

Secondary Outcomes (2)

• Changes in circulating cytokines and chemokines

  4 weeks

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

  4 weeks

Study Arms (2)

Bionocol arm

EXPERIMENTAL

Dietary Supplement: BIOintestil

Placebo arm

PLACEBO COMPARATOR

Dietary Supplement: PLACEBO

Interventions

BIOintestil DIETARY_SUPPLEMENT

Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)

Also known as: BIONOCOL

Bionocol arm

PLACEBO DIETARY_SUPPLEMENT

Cornstarch

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Targeting Gut Disease S.R.L.: lead

Study Sites (1)

A.O.U Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Fernando Rizzello, MD

  A.O.U Policlinico S.Orsola-Malpighi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: April 9, 2020
• Study Start: December 5, 2018
• Primary Completion: September 30, 2020
• Study Completion: January 31, 2021
• Last Updated: April 18, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)