NCT06423001

Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 d.e. tit. 20% polysaccharides, chamomile (Matricaria chamomilla L.) flowers d.e. tit. 0.3% 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.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220.	Each patient will be supplied with the investigational product at Visit 0, PostibiotiX Slowing and at visit 3, based on the outcome of the randomization at V0 (Sequence AB, PostbiotiX Slowing/Placebo; Sequence BA, Placebo/PostbiotiX Slowing).

Timeline

• Start date: 2024-06-15
• Primary completion: 2025-05-15
• Completion: 2026-05-15
• First posted: 2024-05-21
• Last updated: 2024-05-29

Locations

1 site across 1 country: Italy