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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Probiotic formula capsule
Other interventionThe subjects take 4 capsules a day for 84 days.
placebo capsule
Other interventionThe subjects take 4 capsules a day for 84 days.
FMT capsule
Other interventionThe subjects take 4 capsules a day for 84 days.
Treatment groups
156 Participants
are divided into 3 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: Fecal microbiota transplantation (FMT) groupActive comparator 1 intervention
Group C: Probiotic formula groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline
This scale lists 57 items of abnormal performance in sensation, behavior, emotion and language, and makes the judgment of "yes" and "no" in each item. (the informant refers to the parents of the child or those who have lived with the child for more than two weeks.) when scoring, make "yes" and "no" to each item, "yes" is the symbol"√", and "no" is not marked. The total score of "yes" items is 158, and the screening limit is 53-67 points. 53 points were used as the diagnostic threshold of autism, and the diagnosis score was 67 points.
Time frame
week 12Secondary outcomes
1
Changes in Childhood Autism Rating Scale(CARS) before and after treatment
The scale consists of 15 items, which are used by the examiners. Each item of the scale was scored according to 1-4 grades. The total score was greater than or equal to 30 points for diagnosis of autism, less than 36 points for mild-moderate autism, and for severe autism when the total score reached or greater than 36 points.
Time frame
week 0,4,8,12,242
Changes in Social Responsiveness Scale(SRS) before and after treatment
The scale is composed of 65 items in 5 subscales. The content of the scale mainly involves children's daily social situations, including social perception, cognition, communication, motivation, autistic behavior and other aspects. The scale adopts a 4-point rating, and each item has four options: never, sometimes, often, and always, and is completed by parents or long-term caregivers. The higher the score, the more severe the social impairment and autistic behavior.
Time frame
week 0,4,8,123
Changes in Self-Rating Anxiety Scale(SAS) before and after treatment
The scale consists of 20 items. Each item is scored on a scale of 1 to 4, and the final score is the sum of the scores for the 20 items. The final score is multiplied by 1.25 to obtain the integer part, and the standard score is obtained. An anxiety total score below 50 is considered normal; 50-60 is mild, 61-70 is moderate, and above 70 is severe anxiety.
Time frame
week 0,4,8,124
Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment
The scale is a semi-structured, standardized assessment that includes communication, social interaction, play, and restrictive and repetitive behaviors.
Time frame
week 0,4,8,12Sponsors and contacts
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Source ClinicalTrials.gov
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