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

NCT ID: NCT04340661

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2021-01-31

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bionocol arm

Group Type: EXPERIMENTAL

BIOintestil

Intervention Type: DIETARY_SUPPLEMENT

Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)

Placebo arm

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DIETARY_SUPPLEMENT

Cornstarch

Interventions

BIOintestil

Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO

Cornstarch

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BIONOCOL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Targeting Gut Disease S.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Rizzello, MD

Role: PRINCIPAL_INVESTIGATOR

A.O.U Policlinico S.Orsola-Malpighi

Locations

A.O.U Policlinico S.Orsola-Malpighi

Bologna, , Italy

Countries

Italy

Other Identifiers

TGD-01

Identifier Type: -

Identifier Source: org_study_id