A Study on Probiotic Formula in Autistic Children
ConditionAutism Spectrum Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorThird Military Medical University
About this trial
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Probiotic formula capsule
- placebo capsule
- FMT capsule
Treatment groups
156 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov