Trials / Terminated
TerminatedNCT04340661
Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Targeting Gut Disease S.R.L. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | BIOintestil | Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii) |
| DIETARY_SUPPLEMENT | PLACEBO | Cornstarch |
Timeline
- Start date
- 2018-12-05
- Primary completion
- 2020-09-30
- Completion
- 2021-01-31
- First posted
- 2020-04-09
- Last updated
- 2023-04-18
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04340661. Inclusion in this directory is not an endorsement.