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

T

Targeting Gut Disease S.R.L.

Status

Terminated

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: BIOintestil
Dietary Supplement: PLACEBO

Study type

Interventional

Funder types

Industry

Identifiers

NCT04340661
TGD-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

56 participants in 2 patient groups, including a placebo group

Bionocol arm
Experimental group
Treatment:
Dietary Supplement: BIOintestil
Placebo arm
Placebo Comparator group
Treatment:
Dietary Supplement: PLACEBO

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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