Clinical trial NCT04340661: 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
Overall status: TERMINATED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Microbiota
immune system
Lead sponsor: Targeting Gut Disease S.R.L.
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in fecal Microbiota composition
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in circulating cytokines and chemokines
timeFrame: 4 weeks
measure: Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: A.O.U Policlinico S.Orsola-Malpighi
Study officials:
affiliation: A.O.U Policlinico S.Orsola-Malpighi
name: Fernando Rizzello, MD
role: PRINCIPAL_INVESTIGATOR
References: