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| Name | Class |
|---|---|
| Fondazione Serena Onlus - Centro Clinico NeMO Milano | OTHER |
| IRCCS Eugenio Medea | OTHER |
| Istituto Nazionale di Ricovero e Cura per Anziani | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic + fiber | Active Comparator | These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each to be taken once a day:
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| Probiotic + Prebiotic | Experimental | These subjects will be given an active symbiotic preparation consisting of two differently colored sticks of 1500mg each to be taken once a day:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic fiber | Dietary Supplement | Moradyn active prebiotic fiber product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Population 1 : ALS
Inclusion Criteria:
Exclusion Criteria:
Population 2: ADHD
Inclusion Criteria:
Exclusion Criteria:
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute IRCCS Eugenio Medea | Bosisio Parini | LC | 23842 | Italy | ||
| Alessia Fumagalli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39710171 | Derived | 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. |
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| Dietary fiber |
| Dietary Supplement |
Fibregum non-active fiber product |
|
| Probiotic | Dietary Supplement | Defense Plus probiotic complex |
|
| Before and After 3 months of intervention |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Forced Expiratory Volume - 1st second (FEV1) | Expired Volume measured after 1 second during pneumotachography exam | Before and After 3 months of intervention |
| Forced Vital capacity (FVC) | Inspired maximal volume during pneumotachography exam | Before and After 3 months of intervention |
| 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 |
| Casatenovo |
| LC |
| 23880 |
| Italy |
| IBBA-CNR | Milan | 20133 | Italy |
| Centro Clinico NEMO - Fondazione Serena Onlus, Milano | Milan | 20162 | Italy |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D019587 | Dietary Supplements |
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