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

NCT ID: NCT06005506

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Probiotic + fiber

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.

Group Type: ACTIVE_COMPARATOR

Dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

Fibregum non-active fiber product

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Defense Plus probiotic complex

Probiotic + Prebiotic

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).

Group Type: EXPERIMENTAL

Prebiotic fiber

Intervention Type: DIETARY_SUPPLEMENT

Moradyn active prebiotic fiber product

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Defense Plus probiotic complex

Interventions

Prebiotic fiber

Moradyn active prebiotic fiber product

Intervention Type: DIETARY_SUPPLEMENT

Dietary fiber

Fibregum non-active fiber product

Intervention Type: DIETARY_SUPPLEMENT

Probiotic

Defense Plus probiotic complex

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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%.

• 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.

• adults above 18 years of age
• diagnosed with Bronchial Ashtma following ERS-ETS criteria

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

• 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

• life expectancy less than 18 months
• active respiratory infections
• cognitive disorders that prevent participation to the study (MMS <24)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Serena Onlus - Centro Clinico NeMO Milano

OTHER

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: collaborator

Institute of Biomedical Technologies-National Research Council, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, LC, Italy

Alessia Fumagalli

Casatenovo, LC, Italy

IBBA-CNR

Milan, , Italy

Centro Clinico NEMO - Fondazione Serena Onlus, Milano

Milan, , Italy

Countries

Italy

References

Trezzi S, Scaccabarozzi G, Nossa R, Piazza C, Bianchi AR, Rosi E, Tizzoni F, Mauri M, Camillo L, Baragetti A, Molteni M, Campanella V, Mauro L, Cremonesi P, Severgnini M, Monroy MM, Castiglioni B, Sparvoli F, Pisano S, Pozzi M, Crippa A, Nobile M. Behavioural, cognitive, and neurophysiological effects of a synbiotic supplementation enriched with pigmented corn extract or cornstarch in drug-naive children with attention-deficit hyperactivity disorder: A randomised, double-blind, comparison-controlled clinical trial. Clin Nutr ESPEN. 2025 Feb;65:408-417. doi: 10.1016/j.clnesp.2024.12.016. Epub 2024 Dec 20.

Reference Type: DERIVED

PMID: 39710171 (View on PubMed)

Other Identifiers

NM102_SPATIALS3

Identifier Type: -

Identifier Source: org_study_id