Last reviewed · How we verify
NCT06005506: sPATIALS3
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
NA trial testing Prebiotic fiber in Adhd in 64 participants. Completed in 31 March 2023.
31 October 2022
Quick facts
| Lead sponsor | Institute of Biomedical Technologies-National Research Council, Italy |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 64 |
| Start date | 1 October 2021 |
| Primary completion | 31 October 2022 |
| Estimated completion | 31 March 2023 |
| Sites | 4 locations across Italy |
Drugs / interventions tested
- Prebiotic fiber
- Dietary fiber
- Probiotic
Conditions studied
- Adhd — all drugs for Adhd →
- ALS — all drugs for ALS →
- Bronchial Asthma — all drugs for Bronchial Asthma →
Sponsor
Institute of Biomedical Technologies-National Research Council, Italy
Who can join
Eligibility, any sex, with Adhd or ALS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Behavioural, cognitive, and neurophysiological effects of a synbiotic supplementation enriched with pigmented corn extract or cornstarch in drug-naïve children with attention-deficit hyperactivity disorder: A randomised, double-blind, comparison-controlled clinical trial.
Trezzi S, Scaccabarozzi G, Nossa R, Piazza C, et al · · 2025 · cited 2× · PMID 39710171 · DOI 10.1016/j.clnesp.2024.12.016
Verify or expand the search:
- PubMed search for NCT06005506
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Adhd
Currently open trials in the same condition.
- NCT03672266 — Studies of Brain and Body Interaction · recruiting
Other Institute of Biomedical Technologies-National Research Council, Italy trials
Trials by the same sponsor.
- NCT04471701 — Italian Web-based Cross-sectional Survey on COVID-19 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06005506 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Biomedical Technologies-National Research Council, Italy
- Last refreshed: 22 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06005506.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing