NCT05016024

Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome.

A Randomized, Cross-over, Placebo-Controlled, Double-Blind Clinical Trial on the Efficacy and Safety of Oral Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in the Treatment of Irritable Bowel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Aboca Spa Societa' Agricola · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to investigate the efficacy and safety of Colilen IBS, a Medical Device made of natural substances, even when taken in addition to other therapies, for the treatment of Irritable Bowel Syndrome.

Detailed description

This is a Post Market, randomized, double blind, cross-over clinical evaluation that will be conducted in 66 patients with diagnosis of Irritable Bowel Syndrome according to Rome IV criteria. As this is a cross-over clinical investigation, each eligible patient will take both the products under investigation, Colilen IBS and its Placebo. After a 2-week run-in period, at Baseline visit each patient included in the study will be randomly assigned to one of the two treatment sequences (i.e., Sequence AB and Sequence BA), for a 16-week total sequential treatment period (8 weeks for each of the 2 treatment periods) first with verum Colilen IBS and then with its Placebo, or vice versa. A wash out period (3 weeks) is forecast between the two treatment periods.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Colilen IBS	Patients will take Colilen IBS in First or Second Period
OTHER	Placebo	Patients will take PlaceboS in First or Second Period

Timeline

• Start date: 2021-08-05
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2021-08-23
• Last updated: 2023-02-16

Locations

7 sites across 2 countries: Germany, Italy