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NCT Number: NCT06005506

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

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.

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Key information

Conditions

ADHD ALS Asthma Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Bronchial Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mental Disorders Neurodevelopmental Disorders Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scientific Institute IRCCS Eugenio Medea, Bosisio Parini, LC, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prebiotic fiber

Dietary Supplement

Moradyn active prebiotic fiber product

Dietary fiber

Dietary Supplement

Fibregum non-active fiber product

Probiotic

Dietary Supplement

Defense Plus probiotic complex

Primary outcomes

  1. Change in levels of Short Chain Fatty Acids (SCFA)

    Time frame: 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.

  2. Change in levels of branched chain fatty acids (isobutyrate and isovalerate)

    Time frame: 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 outcomes

  1. Conners' Parent Rating Scale-Revised - scale H (ADHD Index)

    Time frame: 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

  2. Conners' Parent Rating Scale-Revised - Scale K (total CGI)

    Time frame: 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

  3. Conners' Parent Rating Scale-Revised - Scale B (attention problem)

    Time frame: 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

  4. Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)

    Time frame: 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

  5. Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)

    Time frame: 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.

  6. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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

  7. Forced Expiratory Volume - 1st second (FEV1)

    Time frame: Before and After 3 months of intervention

    Expired Volume measured after 1 second during pneumotachography exam

  8. Forced Vital capacity (FVC)

    Time frame: Before and After 3 months of intervention

    Inspired maximal volume during pneumotachography exam

  9. Asthma control test score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Institute of Biomedical Technologies-National Research Council, Italy

Other

Collaborators

  • Fondazione Serena Onlus - Centro Clinico NeMO Milano
  • IRCCS Eugenio Medea
  • Istituto Nazionale di Ricovero e Cura per Anziani

Registry information

Official study 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.

Acronym: sPATIALS3

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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