National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microb… (NCT06005506) | Clinical Trial Compass
CompletedNot Applicable
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.
Italy64 participantsStarted 2021-10-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in levels of Short Chain Fatty Acids (SCFA)
Timeframe: Before and After 3 months of intervention
2
Change in levels of branched chain fatty acids (isobutyrate and isovalerate)
Timeframe: Before and After 3 months of intervention
Trial details
NCT IDNCT06005506
SponsorInstitute of Biomedical Technologies-National Research Council, Italy