The Intervention of Lactobacillus Plantarum Probiotics in Adult Patients With Autistic Spectrum Disorders Investigating Associations of Social Interactions, Quality of Life, and Gait Analysis: A Qualitative and Quantitative Mixed & Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Patient Clinical Global Impression of Improvement (CGI-I)
研究概览
简要总结
Phase I: Post-hoc Analysis and Longitudinal Follow-up Due to the inherent difficulty in recruiting the target number of individuals with Autism Spectrum Disorder (ASD) and the logistical challenges related to securing consensus from workshops, families, and teachers, the initial study phase has been modified. The mixed-methods phase will now focus on leveraging the rich qualitative data already collected. We will seek ethical approval and consent from the fifteen preliminary study participants, their families, and teachers to conduct analysis of the existing interview content. Furthermore, these fifteen participants will be invited for a four-month follow-up assessment following the completion of the original 8-week intervention (post-test) to evaluate the persistence of observed changes after probiotic cessation. At this follow-up, teachers will re-evaluate the original three GAS goals, provide open-ended descriptions of the status of those target behaviors, and complete the Autism Behavior Checklist (ABCT). Parents will complete the full battery of questionnaires administered at the Week 8 endpoint.
Phase II: Controlled Trial The trial will consist of an 8-week intervention period. Participants will be assigned into the psychobiotic group and the control group. Gait analysis and subjective evaluations will be conducted at multiple time points, specifically, at Baseline and Week 8 (end of the first intervention period).
详细描述
One neurodevelopmental disease that manifests before the age of three is autism. It is a range of widespread developmental problems that affect people from various socioeconomic backgrounds and ethnicities. Beginning in 2013, autism spectrum disorder (ASD) becomes the general diagnosis given to all children with autism, Asperger's syndrome, or other prevalent developmental abnormalities (DSM-5, APA). Over the past two decades, the frequency of ASD has steadily increased. Greater awareness of the problem or easier access to diagnostic services could be the cause of this.
Children with ASD have difficulties in social interaction, communication, and language skills with many children demonstrating delayed language development, unusual speech patterns, lack of spoken language, challenges in forming peer relationships, restrictive and repetitive behaviours such as rocking or hand flapping, or over- or under-reactive to stimuli. In adults with ASD, they may still have blunt or literal communication style, preference for solitude, difficulty understanding social cues, challenges in maintaining conversations, discomfort in social situations, adherence to routines, repetitive behaviors and sensory sensitivities similar to those seen in childhood but probably more controlled or masked. While the core characteristics of ASD remain consistent, the manifestation of symptoms can change with age and development. Talking with caregivers and other family members to find out about the person's early developmental history will help ensure an accurate diagnosis when diagnosing and evaluating people with ASD. Many adults with ASD struggle with finding and keeping employment, which can affect their independence and quality of life. ASD adults may also have co-occurring health conditions, such as anxiety and depression, which further impact daily functioning and overall well-being.
In recent years, the microbiota and the gut-brain axis (MGB, or the biochemical signaling pathway that connects the gastrointestinal tract and the nervous system) has attracted much attention in regulations and interactions of the nervous and immune systems. Intestinal microbes and their metabolites have been shown to regulate the human body through a series of biochemical and functional linkages. The microbiota is considered to be an essential organ of the human body for maintaining homeostasis. The composition of the intestinal flora is not only related to factors such as age, diet, or metabolic diseases, but also plays key roles in absorption, storage, metabolism, and maintenance of healthy immune function.
As for human research, Proteobacteria, Firmicutes, and Bacteroides are the three primary types of microorganisms found in the gut. They must be in harmony with one another; in fact, dysbiosis, an imbalance, can have an impact on gut health. Recent studies have started to investigate associations of microbiota and mental disorders, including depression or anxiety, autistic spectrum disorder, schizophrenia, or bipolar disorder.
ASD has primarily been examined in clinical trials conducted on children to examine the impacts of probiotics on neurological disorders. The main clinical trials on the effects of probiotics on children with ASD showed both the benefits and the drawbacks. Different probiotic dosages and results employing various beneficial microorganisms have been reported in trials looking into probiotic therapy in children with ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who have been diagnosed with autistic spectrum disorder aged 18~50 years old
- •Those whose primary contacts or caregiver (including family members or teachers) are willing to participate
- •Those whose primary contacts or caregivers can understand Mandarin and can answer relevant questions or questionnaires.
排除标准
- •Have taken antibiotics or are receiving antibiotic treatment within one month.
- •Have used probiotic products in powder, capsule or tablet form within two weeks (excluding yogurt, Yakult and other related foods).
- •Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy).
- •Past or current patients with inflammatory bowel disease.
- •Those with a history of cancer.
- •Those who are allergic to lactic acid bacteria products.
- •Those who are receiving parenteral nutrition.
- •Those who are evaluated by the principal investigator to be unsuitable to participate in the research.
研究组 & 干预措施
Neuralli® MP
Lactobacillus plantarum
干预措施: Lactiplantibacillus plantarum (Dietary Supplement)
结局指标
主要结局
Patient Clinical Global Impression of Improvement (CGI-I)
时间窗: baseline to week8
Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Teacher Target Symptom Rating Visual Analogue Scale (TTSVAS)
时间窗: baseline to week8
This is a tool used by teachers to 5 rate the severity of specific symptoms in their students. It typically involves a visual analogue scale (VAS), where teachers have to state three specific symptoms and mark a point on a line that represents the intensity of a particular symptom, such as irritability, hyperactivity, or anxiety, with score 10 being the most severe. If the symptoms they cared were to build positive behaviors, then score 10 would be the best performance of their students ("The British Pain Society. Outcome measures.," 2019). Teachers will be asked to list three items and quantify and describe baseline problems (frequency, duration, severity, interference with daily life) briefly in words.
次要结局
- Parenting Stress Index Fourth Edition Short Form, PSI-4-SF(baseline to week 8)
- The Autism Behavior Checklist-Taiwan, ABCT(baseline to week 8)
- Quality of Life in Autism Questionnaire, QoLA(baseline to week 8)
- Parent Target Symptom Rating Visual Analogue Scale, PTSVAS(baseline to week 8)
- Teacher's Individualized Service Plans (ISP) goals and records(baseline to week 8)
- Visual Analogue Scale of Gastrointestinal Symptoms(baseline to week 8)
- Parent Global Impression - Revised-2 (PGI-2)(baseline to week 8)
- Teacher Global Impression - Revised-2 (TGI-2)(baseline to week 8)
研究者
Shu-I Wu
Attending Physician
Mackay Memorial Hospital
