AdhdsPATIALS3NCT06005506
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
A study testing Prebiotic fiber, Dietary fiber and Probiotic in people with Adhd and ALS, run by Institute of Biomedical Technologies-National Research Council, Italy at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adhd, ALS, Bronchial Asthma
- What is being tested?
- Prebiotic fiber, Dietary fiber and Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Oct 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at enrollment ≥18 years;
- ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al., 2000);
- Respiratory function with FVC% >50%.
- 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.
- adults above 18 years of age
- diagnosed with Bronchial Ashtma following ERS-ETS criteria
Who cannot join
- 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
- presence of intellectual disability (QIT<70),
- presence of neurological diseases, epilepsy
Show all 13Show fewer
- 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
- life expectancy less than 18 months
- active respiratory infections
- cognitive disorders that prevent participation to the study (MMS <24)
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Alessia Fumagalli
Casatenovo, LC, 23880
IBBA-CNR
Milan, 20133
Centro Clinico NEMO - Fondazione Serena Onlus, Milano
Milan, 20162
About this study
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.
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.
Read the 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.
- Conditions
- Adhd, ALS, Bronchial Asthma
- Being tested
- Prebiotic fiber, Dietary fiber, Probiotic
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic fiberDietary supplement
Moradyn active prebiotic fiber product
Dietary fiberDietary supplement
Fibregum non-active fiber product
ProbioticDietary supplement
Defense Plus probiotic complex
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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. Receives: Dietary Supplement: Dietary fiber; Dietary Supplement: Probiotic |
| 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:
* 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). Receives: Dietary Supplement: Prebiotic fiber; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Before and After 3 months of intervention
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Before and After 3 months of intervention
Forced Expiratory Volume - 1st second (FEV1)
Expired Volume measured after 1 second during pneumotachography exam
Measured: Before and After 3 months of intervention
Forced Vital capacity (FVC)
Inspired maximal volume during pneumotachography exam
Measured: 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)
Measured: Before and After 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdhdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biomedical Technologies-National Research Council, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Serena Onlus - Centro Clinico NeMO Milano, IRCCS Eugenio Medea, Istituto Nazionale di Ricovero e Cura per Anziani
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005506
- Sponsor's protocol ID
- NM102_SPATIALS3
- Acronym
- sPATIALS3
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39710171
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06005506
- Acronym / sponsor ID
- sPATIALS3 / NM102_SPATIALS3
- Conditions
- Adhd, ALS, Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Institute of Biomedical Technologies-National Research Council, ItalyUniversity, hospital or other
- Collaborators
- Fondazione Serena Onlus - Centro Clinico NeMO Milano, IRCCS Eugenio Medea, Istituto Nazionale di Ricovero e Cura per Anziani
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic + fiber | Active comparator | Dietary Supplement: Dietary fiber, Dietary Supplement: ProbioticThese 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. |
| Probiotic + Prebiotic | Experimental | Dietary Supplement: Prebiotic fiber, Dietary Supplement: ProbioticThese 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age at enrollment ≥18 years;
- ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al., 2000);
- Respiratory function with FVC% >50%.
- 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.
Key exclusion criteria (13 listed)
- 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
- presence of intellectual disability (QIT<70),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic fiberMoradyn active prebiotic fiber product | Dietary supplement | Probiotic + Prebiotic |
| Dietary fiberFibregum non-active fiber product | Dietary supplement | Probiotic + fiber |
| ProbioticDefense Plus probiotic complex | Dietary supplement | Probiotic + Prebiotic, Probiotic + fiber |
Primary outcome
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.
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
9 secondary outcomes
Conners' Parent Rating Scale-Revised - scale H (ADHD Index)
Time frame: Before and After 3 months of intervention
Conners' Parent Rating Scale-Revised - Scale K (total CGI)
Time frame: Before and After 3 months of intervention
Conners' Parent Rating Scale-Revised - Scale B (attention problem)
Time frame: Before and After 3 months of intervention
Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)
Time frame: Before and After 3 months of intervention
Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)
Time frame: Before and After 3 months of intervention
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Before and After 3 months of intervention
Forced Expiratory Volume - 1st second (FEV1)
Time frame: Before and After 3 months of intervention
Forced Vital capacity (FVC)
Time frame: Before and After 3 months of intervention
Asthma control test score
Time frame: Before and After 3 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 39710171Trezzi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic fiber, Dietary fiber and Probiotic in people with Adhd and ALS, run by Institute of Biomedical Technologies-National Research Council, Italy at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of Short Chain Fatty Acids (SCFA) (time frame: Before and After 3 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.