NCT06005506

National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.

'sPATIALS3' - National Multicenter Randomized Controlled Interventional Study, Comparing an Active Symbiotic and a Passive Symbiotic Aimed at Evaluating the Effect on the Intestinal Microbiota and on the State of Health and Well-being of Various Types of Chronically Frail Patients United by Alterations of Intestinal Function.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Institute of Biomedical Technologies-National Research Council, Italy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of the study will be to understand whether a supplementation of the diet with an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber with prebiotic activity combined with a vegetable extract with beneficial activities on carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve absorption, intestinal motility and bowel habit of patients with various pathological conditions, such as ALS, ADHD and bronchial asthma.

Detailed description

Clinical survey conducted for research and study purposes, multicenter, focusing on ALS patients, elderly patients with chronic diseases, and pediatric patients with neurodevelopmental disorders. For each of the diseases treated, patients will be randomized into the two treatment arms (Study Group, GS; Control Group, GC) according to a block randomization, with a block size of 4 and an allocation ratio of 1:1. The randomization will be double-blind. * Study Group or GS: These subjects will be given an active symbiotic preparation consisting of two sticks of 1500mg each and of different colors. * Control group or GC:These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each.

Conditions

• Adhd
• ALS
• Bronchial Asthma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic fiber	Moradyn active prebiotic fiber product
DIETARY_SUPPLEMENT	Dietary fiber	Fibregum non-active fiber product
DIETARY_SUPPLEMENT	Probiotic	Defense Plus probiotic complex

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-10-31
• Completion: 2023-03-31
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

4 sites across 1 country: Italy