National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function. (sPATIALS3)

Institute of Biomedical Technologies-National Research Council, Italy

Status: Completed

Conditions: ALS; Bronchial Asthma; Adhd

Treatments: Dietary Supplement: Dietary fiber; Dietary Supplement: Probiotic; Dietary Supplement: Prebiotic fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT06005506

NM102_SPATIALS3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Probiotic + fiber

Active Comparator group

Description:

These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each to be taken once a day: * Purple Sachet - Prebiotic - Composed of 500mg acacia fiber (Fibregum®) with high prebiotic activity and 500mg mai starch. Excipients and flavorings. * White Sachet - Probiotic - 30 Billion bacterial strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus L.

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Dietary fiber

Probiotic + Prebiotic

Experimental group

Description:

These subjects will be given an active symbiotic preparation consisting of two differently colored sticks of 1500mg each to be taken once a day: * Purple Sachet - Active Prebiotic - 500 mg of Fibregum®, a slow-fermenting prebiotic fiber and 500 mg of standardized extract of pigmented Zea Mays L fruit, rich in anthocyanins and polyphenols. Excipients and flavorings. * White Sachet - Probiotic - 30 Billion Bacterial Strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus LA (PBS066 - EU Collection DSM 24936) and Bifidobacterium animalis subsp. lactis BL (BL050 - Eu Collection DSM 25566).

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Prebiotic fiber