A Study on Probiotic Formula in Autistic Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic formula capsule, placebo capsule, FMT capsule.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
Overview
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.
Interventions
- Other Probiotic formula capsule
The subjects take 4 capsules a day for 84 days. - Other placebo capsule
The subjects take 4 capsules a day for 84 days. - Other FMT capsule
The subjects take 4 capsules a day for 84 days.
Primary outcome measures
- Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline [Time frame: week 12]
Secondary outcome measures (8)
- Changes in Childhood Autism Rating Scale(CARS) before and after treatment [Time frame: week 0,4,8,12,24]
- Changes in Social Responsiveness Scale(SRS) before and after treatment [Time frame: week 0,4,8,12]
- Changes in Self-Rating Anxiety Scale(SAS) before and after treatment [Time frame: week 0,4,8,12]
- Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment [Time frame: week 0,4,8,12]
- Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment [Time frame: week 0,4,8,12, 24]
- Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment [Time frame: week 0,12]
- Changes in gut microbiota of children with autism before and after treatment [Time frame: week 0,12]
- Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment [Time frame: week 0,4,8, 24]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Gastroenterology, Daping Hospital, The Third Military Medical University — Chongqing
Identifiers
NCT: NCT06419530 · TMMU-DP-ASD-PMT-20240510