Clinical trial NCT06005506: National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
Official title: '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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhd
ALS
Bronchial Asthma
Lead sponsor: Institute of Biomedical Technologies-National Research Council, Italy
Sponsor class: OTHER
Collaborators: name: Fondazione Serena Onlus - Centro Clinico NeMO Milano
name: IRCCS Eugenio Medea
name: Istituto Nazionale di Ricovero e Cura per Anziani
First posted: 2023-08-22
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
measure: Change in levels of Short Chain Fatty Acids (SCFA)
timeFrame: Before and After 3 months of intervention
measure: Change in levels of branched chain fatty acids (isobutyrate and isovalerate)
timeFrame: Before and After 3 months of intervention
Secondary outcomes:
measure: Conners' Parent Rating Scale-Revised - scale H (ADHD Index)
timeFrame: Before and After 3 months of intervention
measure: Conners' Parent Rating Scale-Revised - Scale K (total CGI)
timeFrame: Before and After 3 months of intervention
measure: Conners' Parent Rating Scale-Revised - Scale B (attention problem)
timeFrame: Before and After 3 months of intervention
measure: Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)
timeFrame: Before and After 3 months of intervention
measure: Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)
timeFrame: Before and After 3 months of intervention
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Before and After 3 months of intervention
measure: Forced Expiratory Volume - 1st second (FEV1)
timeFrame: Before and After 3 months of intervention
measure: Forced Vital capacity (FVC)
timeFrame: Before and After 3 months of intervention
measure: Asthma control test score
timeFrame: Before and After 3 months of intervention
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS Eugenio Medea
state: LC
city: Casatenovo
country: Italy
facility: Alessia Fumagalli
state: LC
city: Milan
country: Italy
facility: IBBA-CNR
city: Milan
country: Italy
facility: Centro Clinico NEMO - Fondazione Serena Onlus, Milano
Study officials:
References: