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

Institute of Biomedical Technologies-National Research Council, Italy64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Adhd ALS

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Population 1 : ALS Inclusion Criteria: * Age at enrollment ≥18 years; * ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al., 2000); * Respiratory function with FVC% \>50%. Exclusion Criteria: * Subjects unable to give informed consent to the study; * presence of psychiatric disease or severe cognitive impairment; * presence of tracheotomy; presence of severe pre-existing gastrointestinal disease (e.g., ulcerative rectocolitis; Crohn's disease). Population 2: ADHD Inclusion Criteria: * children between 6 and 16 years old * children with ADHD, diagnosed with DSM-5 criteria and in accordance with the protocol shared by the Regional ADHD Reference Centers Lombardy. Exclusion Criteria: * presence of intellectual disability (QIT\<70), * presence of neurological diseases, epilepsy * presence of genetic syndromes * treatment with drug therapies. Co-diagnosis with other psychiatric or neurodevelopmental disorders (i.e. Autism, Anxiety, Depression etc) will not be considered a criterion of exclusion. Population 3: Bronchial Ashtma Inclusion Criteria: * adults above 18 years of age * diagnosed with Bronchial Ashtma following ERS-ETS criteria Exclusion Criteria: * life expectancy less than 18 months * active respiratory infections * cognitive disorders that prevent participation to the study (MMS \<24)

Outcomes

Primary Outcomes

Change in levels of Short Chain Fatty Acids (SCFA)

Evaluation of pre-post treatment variation of the level of specific SCFAs (acetic acid, propionic acid, butyric acid and valeric acid) both within the group of the treated and between the group of treated patients and the placebo group.