Adhd, ALS, Bronchial Asthma
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic fiber
Moradyn active prebiotic fiber product
DIETARY_SUPPLEMENTDietary fiber
Fibregum non-active fiber product
DIETARY_SUPPLEMENTProbiotic
Defense Plus probiotic complex
Sponsors
Fondazione Serena Onlus - Centro Clinico NeMO Milano
IRCCS Eugenio Medea
Istituto Nazionale di Ricovero e Cura per Anziani
Institute of Biomedical Technologies-National Research Council, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed