RCT of Autism spectrum disorder and probiotics

RCT of Autism spectrum disorder and probiotics - Autism and probiotics study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033113

Enrollment

100

Registered

2018-07-01

Start date

2019-08-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Patients with ASD symptoms due to secondary failure (e.g.cerebral palsy, brain tumor, and neurologic organic disease).

Design outcomes

Primary

Measure	Time frame
Clinical psychiatiric improvement measured by VABS and ABC before and after administration.	—

Secondary

Measure	Time frame
Improvement of gastrointestinal symptoms scores of QPGS-RIII, increasing urine basal Oxytocin and diversity of microbiome and PCA.	—

Countries

Japan

Contacts

Public ContactMegumi Kubota

Kubota children's clinic pediatrics

meg@ki.rim.or.jp06-7894-1100

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026