Status:
COMPLETED
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
Lead Sponsor:
Institute of Biomedical Technologies-National Research Council, Italy
Collaborating Sponsors:
Fondazione Serena Onlus - Centro Clinico NeMO Milano
IRCCS Eugenio Medea
Conditions:
Adhd
ALS
Eligibility:
All Genders
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- Population 1 : ALS
- 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
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06005506
Start Date
October 1 2021
End Date
March 31 2023
Last Update
August 22 2023
Active Locations (4)
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1
Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, LC, Italy, 23842
2
Alessia Fumagalli
Casatenovo, LC, Italy, 23880
3
IBBA-CNR
Milan, Italy, 20133
4
Centro Clinico NEMO - Fondazione Serena Onlus, Milano
Milan, Italy, 20162