Unique ID issued by UMIN | UMIN000033113 |
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Receipt number | R000037759 |
Scientific Title | RCT of Autism spectrum disorder and probiotics |
Date of disclosure of the study information | 2018/07/01 |
Last modified on | 2019/10/20 23:04:59 |
RCT of Autism spectrum disorder and probiotics
Autism and probiotics study
RCT of Autism spectrum disorder and probiotics
Autism and probiotics study
Japan |
Autism spectrum disorder
Pediatrics |
Others
NO
We postulate that children with autism spectrum disorder (ASD) receiving Lactobacillus Reuteri DSM 17938 will make improvements in their behavior and investigate the change of their urine basal oxytocin and microbiota. We will examine the improvements of symptoms associated to change of microbiome and urine basal oxytocin.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Clinical psychiatiric improvement measured by VABS and ABC before and after administration.
Improvement of gastrointestinal symptoms scores of QPGS-RIII, increasing urine basal Oxytocin and diversity of microbiome and PCA.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Group A (10):L.reuteri DSM 17938 and L.reuteri ATCC PTA 6475 (GASTRUS R)4x108(2Tx2 in a day)for 6 months
Group B (10): Placebo
6 months
6 | years-old | <= |
18 | years-old | > |
Male and Female
Children diagnosed ASD by neurologist or psychiatrist based on DSM-V with some gastrointestinal symptoms (at least one of IBS symptoms [diarrhea, constipation, and recurrence abdominal pain]).6to18 years old, gender does't matter. Patients who refer to resercher's outpatients clinic during conducting of survey period and get the written request mentioned acknowledgement to informed concent.
Patients with ASD symptoms due to secondary failure (e.g.cerebral palsy, brain tumor, and neurologic organic disease).
100
1st name | Megumi |
Middle name | |
Last name | Kubota |
Kubota children's clinic
Pediatrics
5440033
2-6-18 Kitakatsuyama Ikunoku Osaka
06-7894-1100
meg@ki.rim.or.jp
1st name | Megumi |
Middle name | |
Last name | Kubota |
Kubota children's clinic
pediatrics
5440033
2-6-18 Kitakatsuyama Ikunoku Osaka
06-7894-1100
http://www.kubota-kids.com/
meg@ki.rim.or.jp
Kubota children's clinic
Biogaia AB
Outside Japan
Sweden
Osaka University of Medicine
2-2 Yamadagaoka Suitasi Osaka
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
NO
くぼたこどもクリニック
2018 | Year | 07 | Month | 01 | Day |
http://www.kubota-kids.com/
Unpublished
http://www.kubota-kids.com/
Open public recruiting
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 07 | Month | 13 | Day |
2019 | Year | 08 | Month | 01 | Day |
2021 | Year | 08 | Month | 01 | Day |
2021 | Year | 08 | Month | 01 | Day |
2021 | Year | 08 | Month | 01 | Day |
2021 | Year | 08 | Month | 01 | Day |
2018 | Year | 06 | Month | 22 | Day |
2019 | Year | 10 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037759
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