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

Adhd Clinical Trial

— sPATIALS3  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06005506
• Other study ID #: NM102_SPATIALS3
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2023
• Source: Institute of Biomedical Technologies-National Research Council, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Adhd
• ALS
• Asthma
• Bronchial Asthma

Intervention

Dietary Supplement:
• Prebiotic fiber
Moradyn active prebiotic fiber product
• Dietary fiber
Fibregum non-active fiber product
• Probiotic
Defense Plus probiotic complex

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS Eugenio Medea	Bosisio Parini	LC
Italy	Alessia Fumagalli	Casatenovo	LC
Italy	Centro Clinico NEMO - Fondazione Serena Onlus, Milano	Milan
Italy	IBBA-CNR	Milan

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Biomedical Technologies-National Research Council, Italy	Fondazione Serena Onlus - Centro Clinico NeMO Milano, IRCCS Eugenio Medea, Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before and After 3 months of intervention
Primary	Change in levels of branched chain fatty acids (isobutyrate and isovalerate)	Evaluation of the pre-post nutritional variation of the level of branched chain fatty acids (isobutyrate and isovalerate) between the group of treated patients and the placebo group	Before and After 3 months of intervention
Secondary	Conners' Parent Rating Scale-Revised - scale H (ADHD Index)	The score of subscale H on the Conners' Parent Rating Scale-Revised allows to identify children / adolescents at risk of ADHD.; The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100; Higher scores correspond to greater severity: >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range; = 55 non problematic	Before and After 3 months of intervention
Secondary	Conners' Parent Rating Scale-Revised - Scale K (total CGI)	The score of subscale K on the Conners' Parent Rating Scale-Revised reflects a general problem behavior. A high score indicates a hyperactivity problem, often associated with other problem areas.; The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100; Higher scores correspond to greater severity: >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range; = 55 non problematic	Before and After 3 months of intervention
Secondary	Conners' Parent Rating Scale-Revised - Scale B (attention problem)	Higher scores in the subscale B on the Conners' Parent Rating Scale-Revised are are related to lower learning abilities and difficulties in sustaining prolonged levels of attention.; The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100; Higher scores correspond to greater severity: >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range; = 55 non problematic	Before and After 3 months of intervention
Secondary	Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)	Higher scores in the subscale C on the Conners' Parent Rating Scale-Revised are indicative of higher levels of restlessness and impulsivity.; The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100; Higher scores correspond to greater severity: >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range; = 55 non problematic	Before and After 3 months of intervention
Secondary	Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)	Functional assessment of disease state. maximum score 4 - minimum score 0; for 12 items. indicates normal condition - 0 corresponds to a degree of major severity. The total score can range from a minimum of 0 to a maximum of 48; a score <29 indicates rapid disease progression.	Before and After 3 months of intervention
Secondary	Gastrointestinal Symptom Rating Scale (GSRS)	Represents the main symptoms complained about by the patients. maximum score "Unbearable disturbances" - minimum score "No disturbance"; for 15 items.; The scores follow these directions: No disturbance Mild disturbances Bearable disturbances Moderate disturbances Somewhat severe disturbances Severe disturbances Unbearable disturbances	Before and After 3 months of intervention
Secondary	Forced Expiratory Volume - 1st second (FEV1)	Expired Volume measured after 1 second during pneumotachography exam	Before and After 3 months of intervention
Secondary	Forced Vital capacity (FVC)	Inspired maximal volume during pneumotachography exam	Before and After 3 months of intervention
Secondary	Asthma control test score	Test containing items related to cough and breathlessness, validated in asthmatic subjects; Test contains five items scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled)	Before and After 3 months of intervention