Clinical trial NCT06419530: A Study on Probiotic Formula in Autistic Children
Official title: A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Gut microbiota
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 156
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.

Detailed description: Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents aged 3-11 years old
* Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances)
* With guardians who can fully understand the informed consent and voluntarily sign the written informed consent

Exclusion Criteria:

* Antibiotics or probiotics used within 1 mont
* Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
* Medications related to mental disorders or depression
* Relying on tube feeding
* Swallowing dysfunction that unable to take capsules
* History of severe allergies
* Paticipation in other clinical studies within 4 weeks
* Poor compliance and have difficulty in completing follow-up.

Primary outcomes:
measure: Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline
timeFrame: week 12
Secondary outcomes:
measure: Changes in Childhood Autism Rating Scale(CARS) before and after treatment
timeFrame: week 0,4,8,12,24
measure: Changes in Social Responsiveness Scale(SRS) before and after treatment
timeFrame: week 0,4,8,12
measure: Changes in Self-Rating Anxiety Scale(SAS) before and after treatment
timeFrame: week 0,4,8,12
measure: Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment
timeFrame: week 0,4,8,12
measure: Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment
timeFrame: week 0,4,8,12, 24
measure: Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment
timeFrame: week 0,12
measure: Changes in gut microbiota of children with autism before and after treatment
timeFrame: week 0,12
measure: Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment
timeFrame: week 0,4,8, 24
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Gastroenterology, Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital,Army medical university
name: Yanling Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: