MacKay Memorial Hospital
Taipei, Taiwan, 10449
NCT Number: NCT07118267
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).
This study is active but is not currently recruiting participants.
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Taipei, Taiwan, 10449
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.
While there's a growing body of research suggesting a potential link between gut health and neurodevelopmental disorders like ASD, most clinical trials of probiotics have been focusing on children. As of now, there aren't many large-scale, randomized controlled trials specifically targeting adults with ASD and probiotic interventions. However, the increasing recognition of the gut-brain axis and the potential benefits of probiotics in various conditions, including mental health, makes this an area of active research. The gut microbiome and its influence on brain function may differ between children and adults. The long-term effects of probiotic interventions on adult ASD symptoms need to be evaluated. The response to probiotic therapy can vary significantly among individuals due to the complex nature of ASD. While there's promising potential, more rigorous scientific research is required to establish the efficacy and safety of probiotics as a treatment for adults with ASD. However, research on the effects of probiotics or Lactobacillus plantarum on adults with ASD diagnosed in childhood still lacking. This study aims to examine whether Lactobacillus plantarum may be a possible new dietary approach for improving behavioral symptoms and enhancing the quality of life of caregivers among adults ASD diagnosed since childhood. This study also intends to outline the potential mechanisms by which the probiotics' direct or mediating effects can alleviate the microbiota-gut-grain dysfunction in the management of adults with ASD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
containing 60 billion CFU (administered as two capsules per day)
Time frame: 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.
Time frame: baseline to week 8
The Checklist scale contains 47 items: 8 items pertaining to sensory (sensation and perception), 11 items to relating (social connection), 12 items pertaining to body and object use (motor activity and rigid object use), 8 items pertaining to language (communication and interaction), and 8 items pertaining to social and self-Help (adaptability and self-care). The scoring method gives 1 point for each "Yes" answer. The higher the score, the more severe the autistic behaviors. This scale has favorable content consistency, with a Cronbach α value between 0.75 and 0.87, retest reliability at 0.89. The content validity and reliability of the scale are satisfactory.
Time frame: baseline to week 8
A 100mm horizontal scale will be used to evaluate the descriptions and ratings, with each 10mm segment representing one unit. The scale ranges from "very good" or "completely resolved" (0) to "worst" or "catastrophic worsening" (10), with 5 representing no change.
Time frame: baseline to week 8
Given the heterogeneous nature of ASD and the limitations of standardized scales in capturing treatment-sensitive functional change, the Goal Attainment Scale (GAS) will be employed as an individualized outcome measure only in the follow up study. The GAS targets will be formally derived from the participants' Individualized Service Plans (ISP), which outline the prioritized functional and behavioral goals set by the teachers and clinicians.
Time frame: baseline to week 8
The "Quality of Life in Autism Questionnaire" (QoLA) is a scale specifically designed for parents or caregivers of children with autism, aiming to assess their quality of life. The questionnaire consists of two parts:
Part A: Evaluates the overall sense of quality of life experienced by the parent or caregiver. This section includes various items such as: "I feel happy and content" and "I am satisfied with my social life." Part B: Assesses the impact of the child's autism symptoms or characteristics on the parent or caregiver. The items in this section aim to understand how the child's autistic traits affect family life and the parent's daily experiences.
The full questionnaire contains 48 items and is designed to comprehensively evaluate both the quality of life of the parent or caregiver and the impact of the child's autism symptoms on them.
Time frame: baseline to week 8
In order to identify relevant gastrointestinal discomfort after the consumption of psychobiotics or the placebo, a VAS with the scores from 0~10 was designed. 10 gastrointestinal symptoms, including dry mouth, difficulty swallowing, decreased appetite, nausea or vomiting, flatulence, gastralgia, upper and lower abdominal pain, constipation, and diarrhea, before and after the intervention were compared to determine the safety and tolerability of the intervention.
Time frame: baseline to week 8
Assesses changes in 17 symptoms, such as language, attention span, cognition, gastrointestinal symptoms, sleep, behaviour, sociability, sensitivity, hyperactivity, aggression, eye contact, mood, and anxiety. The rating was done using a seven-point scale: -3 (much worse), -2 (worse), -1 (slightly worse), 0 (no change), 1 (slightly better), 2 (better) and 3 (much better).
Time frame: baseline to week 8
Assesses changes in 17 symptoms, such as language, attention span, cognition, 6 gastrointestinal symptoms, sleep, behaviour, sociability, sensitivity, hyperactivity, aggression, eye contact, mood, and anxiety. The rating was done using a seven-point scale: -3 (much worse), -2 (worse), -1 (slightly worse), 0 (no change), 1 (slightly better), 2 (better) and 3 (much better).
Mackay Memorial Hospital
Other
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
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