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

Not Applicable

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: BIOintestil; Dietary Supplement: PLACEBO

• Registration Number: NCT04340661
• Lead Sponsor: Targeting Gut Disease S.R.L.

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.

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2019-09-03
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Primary Completion: 2020-09-30
• Study Completion: 2021-01-31
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bionocol arm	BIOintestil	-
Placebo arm	PLACEBO	-

Primary Outcome Measures

Name	Time	Method
Changes in fecal Microbiota composition	4 weeks	relative abundance of bacteroidetes

Secondary Outcome Measures

Name	Time	Method
Changes in circulating cytokines and chemokines	4 weeks	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	4 weeks	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").

Trial Locations

Locations (1)

A.O.U Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy