Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423001
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-24
Brief Title:
Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
A Randomized Cross-over Placebo-Controlled Double-Blind Clinical Trial on the Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
prePO23
Brief Summary:
Irritable bowel syndrome IBS is a highly prevalent functional pathology which currently has no real standardized and effective therapy despite having a significant impact on quality of life and on social-health costs
Post-biotics have demonstrated in various in vitro and in vivo studies the ability to modulate the microbiota the intestinal barrier function the immune response as well as having systemic effects with prospects for good efficacy in treatment of IBS
Post-biotics have demonstrated in various in vitro and in vivo studies the ability to modulate the microbiota the intestinal barrier function the immune response as well as having systemic effects with prospects for good efficacy in treatment of IBS
Detailed Description:
PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220 mallow and chamomile
The Fermented FOS from Lactobacillus paracasei CNCM I-5220 postbiotic is the result of a controlled fermentation The fermentation process allows to eliminate all the individual variability that depends on the microbiota the diet and the psycho-physical conditions of the single individual offering a mixture of bacterial metabolites and fermented fiber postbiotic which has the functional activity In addition as FOS is already fermented it does not induce the formation of gas typical of fiber fermentation in IBS patients thus providing all the beneficial effects of the fiber without its side effects
The fermented FOS from Lactobacillus paracasei CNCM I-5220 postbiotic is easily absorbed by the gut
Dosage and method of use PostbiotiX Slowing 4 g sachets administered at the dosage of one sachet a day To pour the contents of the sachet in a glass add 150 ml of water mix until complete dissolution of the powder and taken immediately preferably as soon as awakened and away from meals
Ingredients Maltodextrin Aroma Fermented FOS from Lactobacillus paracasei CNCM I-5220 mallow Malva sylvestris L flowers and leaves de tit 20 polysaccharides chamomile Matricaria chamomilla L flowers de tit 03 apigenin acidity regulator citric acid anti-caking agent silicon dioxide sweetener sucralose
Conservation method to be kept in a cool and dry place away from light humidity and direct sources of heat
The Fermented FOS from Lactobacillus paracasei CNCM I-5220 postbiotic is the result of a controlled fermentation The fermentation process allows to eliminate all the individual variability that depends on the microbiota the diet and the psycho-physical conditions of the single individual offering a mixture of bacterial metabolites and fermented fiber postbiotic which has the functional activity In addition as FOS is already fermented it does not induce the formation of gas typical of fiber fermentation in IBS patients thus providing all the beneficial effects of the fiber without its side effects
The fermented FOS from Lactobacillus paracasei CNCM I-5220 postbiotic is easily absorbed by the gut
Dosage and method of use PostbiotiX Slowing 4 g sachets administered at the dosage of one sachet a day To pour the contents of the sachet in a glass add 150 ml of water mix until complete dissolution of the powder and taken immediately preferably as soon as awakened and away from meals
Ingredients Maltodextrin Aroma Fermented FOS from Lactobacillus paracasei CNCM I-5220 mallow Malva sylvestris L flowers and leaves de tit 20 polysaccharides chamomile Matricaria chamomilla L flowers de tit 03 apigenin acidity regulator citric acid anti-caking agent silicon dioxide sweetener sucralose
Conservation method to be kept in a cool and dry place away from light humidity and direct sources of heat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None