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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04340661
• Other study ID #: TGD-01
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2020
• Source: Targeting Gut Disease S.R.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: January 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• BIOintestil
Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)
• PLACEBO
Cornstarch

Locations

Country	Name	City	State
Italy	A.O.U Policlinico S.Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Targeting Gut Disease S.R.L.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fecal Microbiota composition	relative abundance of bacteroidetes	4 weeks
Secondary	Changes in circulating cytokines and chemokines	IL-1ß, IL-4, IL-6, IL-10,IL-17A,IL-17F, IL-21, IL-22, IL-23, IL-25, IL31, IL-33, IFN-?, MIP-1b , MCP-1 cytokines and chemokines will be evaluated	4 weeks
Secondary	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