'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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Change in levels of Short Chain Fatty Acids (SCFA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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)
结局指标
主要结局
Change in levels of Short Chain Fatty Acids (SCFA)
时间窗: 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)
时间窗: 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
次要结局
- Forced Vital capacity (FVC)(Before and After 3 months of intervention)
- Conners' Parent Rating Scale-Revised - Scale B (attention problem)(Before and After 3 months of intervention)
- Conners' Parent Rating Scale-Revised - Scale K (total CGI)(Before and After 3 months of intervention)
- Forced Expiratory Volume - 1st second (FEV1)(Before and After 3 months of intervention)
- Conners' Parent Rating Scale-Revised - scale H (ADHD Index)(Before and After 3 months of intervention)
- Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)(Before and After 3 months of intervention)
- Asthma control test score(Before and After 3 months of intervention)
- Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)(Before and After 3 months of intervention)
- Gastrointestinal Symptom Rating Scale (GSRS)(Before and After 3 months of intervention)