UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033113 |
|---|---|
| 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 | 2026/06/29 16:26:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
RCT of Autism spectrum disorder and probiotics
Acronym
Autism and probiotics study
Scientific Title
RCT of Autism spectrum disorder and probiotics
Scientific Title:Acronym
Autism and probiotics study
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical psychiatiric improvement measured by VABS and ABC before and after administration.
Key secondary outcomes
Improvement of gastrointestinal symptoms scores of QPGS-RIII, increasing urine basal Oxytocin and diversity of microbiome and PCA.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Group A (10):L.reuteri DSM 17938 and L.reuteri ATCC PTA 6475 (GASTRUS R)4x108(2Tx2 in a day)for 6 months
Interventions/Control_2
Group B (10): Placebo
6 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
Patients with ASD symptoms due to secondary failure (e.g.cerebral palsy, brain tumor, and neurologic organic disease).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Kubota |
Organization
Kubota children's clinic
Division name
Pediatrics
Zip code
5440033
Address
2-6-18 Kitakatsuyama Ikunoku Osaka
TEL
06-7894-1100
meg@ki.rim.or.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Kubota |
Organization
Kubota children's clinic
Division name
pediatrics
Zip code
5440033
Address
2-6-18 Kitakatsuyama Ikunoku Osaka
TEL
06-7894-1100
Homepage URL
http://www.kubota-kids.com/
meg@ki.rim.or.jp
Sponsor or person
Institute
Kubota children's clinic
Institute
Department
Personal name
Funding Source
Organization
Biogaia AB
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Sweden
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University of Medicine
Address
2-2 Yamadagaoka Suitasi Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
くぼたこどもクリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.kubota-kids.com/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.kubota-kids.com/
Number of participants that the trial has enrolled
60
Results
There is no significant difference in all point of view.
Results date posted
| 2026 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
The subjects were individuals who visited the researcher's outpatient clinic during the study period and provided informed consent. The study included children >=6 years old but <18 years old who were diagnosed with ASD based on ICD-10 criteria by a pediatric neurologist or clinical psychologist.
Participant flow
This was a double-blind placebo-controlled randomized study. The subjects were randomly assigned upon arrival and consent was obtained. An automatically generated randomization list was used for patient allocation. When consent was obtained from the subjects and their guardians, the allocation officer was notified. The officer then performed the registration and allocation according to the randomization table.
Adverse events
nothing
Outcome measures
Psychiatric symptoms were scored using the SRS-2 and ABC before and after the administration of L. reuteri, and changes in each item were analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037759
