Irritable Bowel Syndrome
Conditions
Keywords
Microbiota, immune system
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.
Interventions
DIETARY_SUPPLEMENTBIOintestil
Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)
DIETARY_SUPPLEMENTPLACEBO
Cornstarch
Sponsors
Targeting Gut Disease S.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fecal Microbiota composition | 4 weeks | relative abundance of bacteroidetes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Italy
Outcome results
None listed