sPATIALS3: National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
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Study Group or GS: These subjects will be given an active symbiotic preparation consisting of two sticks of 1500mg each and of different colors.
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Control group or GC:These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Dietary Supplement: Dietary fiber
Fibregum non-active fiber product
Dietary Supplement: Probiotic
Defense Plus probiotic complex
|
| Experimental: 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). |
Dietary Supplement: Prebiotic fiber
Moradyn active prebiotic fiber product
Dietary Supplement: Probiotic
Defense Plus probiotic complex
|
Outcome Measures
Primary Outcome Measures
- Change in levels of Short Chain Fatty Acids (SCFA) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
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) [Before and After 3 months of intervention]
Expired Volume measured after 1 second during pneumotachography exam
- Forced Vital capacity (FVC) [Before and After 3 months of intervention]
Inspired maximal volume during pneumotachography exam
- Asthma control test score [Before and After 3 months of intervention]
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)
Eligibility Criteria
Criteria
Population 1 : ALS
Inclusion Criteria:
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Age at enrollment ≥18 years;
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ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al., 2000);
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Respiratory function with FVC% >50%.
Exclusion Criteria:
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Subjects unable to give informed consent to the study;
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presence of psychiatric disease or severe cognitive impairment;
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presence of tracheotomy; presence of severe pre-existing gastrointestinal disease (e.g., ulcerative rectocolitis; Crohn's disease).
Population 2: ADHD
Inclusion Criteria:
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children between 6 and 16 years old
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children with ADHD, diagnosed with DSM-5 criteria and in accordance with the protocol shared by the Regional ADHD Reference Centers Lombardy.
Exclusion Criteria:
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presence of intellectual disability (QIT<70),
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presence of neurological diseases, epilepsy
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presence of genetic syndromes
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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:
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adults above 18 years of age
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diagnosed with Bronchial Ashtma following ERS-ETS criteria
Exclusion Criteria:
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life expectancy less than 18 months
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active respiratory infections
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cognitive disorders that prevent participation to the study (MMS <24)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scientific Institute IRCCS Eugenio Medea | Bosisio Parini | LC | Italy | 23842 |
| 2 | Alessia Fumagalli | Casatenovo | LC | Italy | 23880 |
| 3 | IBBA-CNR | Milan | Italy | 20133 | |
| 4 | Centro Clinico NEMO - Fondazione Serena Onlus, Milano | Milan | Italy | 20162 |
Sponsors and Collaborators
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NM102_SPATIALS3