Back to resultsNational Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function. (sPATIALS3)
Primary Purpose
Adhd, ALS, Bronchial Asthma
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Prebiotic fiber
Dietary fiber
Probiotic
Sponsored by
About this trial
This is an interventional supportive care trial for Adhd
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)
Sites / Locations
- Scientific Institute IRCCS Eugenio Medea
- Alessia Fumagalli
- IBBA-CNR
- Centro Clinico NEMO - Fondazione Serena Onlus, Milano
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Probiotic + fiber
Probiotic + Prebiotic
Arm 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.
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).
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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
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
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
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
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.
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
Forced Expiratory Volume - 1st second (FEV1)
Expired Volume measured after 1 second during pneumotachography exam
Forced Vital capacity (FVC)
Inspired maximal volume during pneumotachography exam
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)
Full Information
NCT ID
NCT06005506
First Posted
July 10, 2023
Last Updated
August 21, 2023
Sponsor
Institute of Biomedical Technologies-National Research Council, Italy
Collaborators
Fondazione Serena Onlus - Centro Clinico NeMO Milano, IRCCS Eugenio Medea, Istituto Nazionale di Ricovero e Cura per Anziani
1. Study Identification
Unique Protocol Identification Number
NCT06005506
Brief Title
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biomedical Technologies-National Research Council, Italy
Collaborators
Fondazione Serena Onlus - Centro Clinico NeMO Milano, IRCCS Eugenio Medea, Istituto Nazionale di Ricovero e Cura per Anziani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhd, ALS, Bronchial Asthma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic + fiber
Arm Type
Active Comparator
Arm 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.
Arm Title
Probiotic + Prebiotic
Arm Type
Experimental
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic fiber
Intervention Description
Moradyn active prebiotic fiber product
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary fiber
Intervention Description
Fibregum non-active fiber product
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Defense Plus probiotic complex
Primary Outcome Measure Information:
Title
Change in levels of Short Chain Fatty Acids (SCFA)
Description
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.
Time Frame
Before and After 3 months of intervention
Title
Change in levels of branched chain fatty acids (isobutyrate and isovalerate)
Description
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
Time Frame
Before and After 3 months of intervention
Secondary Outcome Measure Information:
Title
Conners' Parent Rating Scale-Revised - scale H (ADHD Index)
Description
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
Time Frame
Before and After 3 months of intervention
Title
Conners' Parent Rating Scale-Revised - Scale K (total CGI)
Description
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
Time Frame
Before and After 3 months of intervention
Title
Conners' Parent Rating Scale-Revised - Scale B (attention problem)
Description
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
Time Frame
Before and After 3 months of intervention
Title
Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)
Description
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
Time Frame
Before and After 3 months of intervention
Title
Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)
Description
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.
Time Frame
Before and After 3 months of intervention
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
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
Time Frame
Before and After 3 months of intervention
Title
Forced Expiratory Volume - 1st second (FEV1)
Description
Expired Volume measured after 1 second during pneumotachography exam
Time Frame
Before and After 3 months of intervention
Title
Forced Vital capacity (FVC)
Description
Inspired maximal volume during pneumotachography exam
Time Frame
Before and After 3 months of intervention
Title
Asthma control test score
Description
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)
Time Frame
Before and After 3 months of intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Scientific Institute IRCCS Eugenio Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
Facility Name
Alessia Fumagalli
City
Casatenovo
State/Province
LC
ZIP/Postal Code
23880
Country
Italy
Facility Name
IBBA-CNR
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Centro Clinico NEMO - Fondazione Serena Onlus, Milano
City
Milan
ZIP/Postal Code
20162
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
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