Safety and efficacy of a novel fecal microbiota transplantation method using hydrogen nanobubble water without antibiotics or bowel cleansing in children with autism spectrum disorder: an open-label, single-arm study demonstrating improvements in core and comorbidity symptoms.
Masahiko Shirotani, Shin Shimizu, Kunihiro Kitamura, Yasuhito Mikawa, Reiko Haruna, Yuichi Kawai, Seiji Koide, Ikuko Mohri, Hideo Matsuzaki, Kenji J Tsuchiya, Yoshimu Tanaka, Taiichi Katayama · Frontiers in pediatrics · 2026
Research-use notice
Independent study record
Each H2HUBB study page organizes source-linked research details for educational use. Interpretation should remain proportional to the study design, population, controls, and limitations.
H2HUBB TAKEAWAY
In Secondary outcomes included sensory profile [Short Sensory Profile (SSP)], gastrointestinal symptoms [Gastrointestinal Symptom Rating Scale [GSRS], Bristol Stool Form Scale [BSFS]] and Patient Health, this novel hydrogen nanobubble water-based FMT method was safe and effective, reducing both core and peripheral symptoms of ASD and suggesting broad benefits via the gut microbiota-brain axis.Clinical Trial Registration: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031230041. These findings add human evidence supporting molecular hydrogen's therapeutic potential across the specific human outcomes evaluated in this study.
What the Findings Mean
H2HUBB reviewed how molecular hydrogen affected the outcomes measured in Secondary outcomes included sensory profile [Short Sensory Profile (SSP)], gastrointestinal symptoms [Gastrointestinal Symptom Rating Scale [GSRS], Bristol Stool Form Scale [BSFS]] and Patient Health. This novel hydrogen nanobubble water-based FMT method was safe and effective, reducing both core and peripheral symptoms of ASD and suggesting broad benefits via the gut microbiota-brain axis.Clinical Trial Registration: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031230041.
What the Researchers Studied
The researchers studied Secondary outcomes included sensory profile [Short Sensory Profile (SSP)], gastrointestinal symptoms [Gastrointestinal Symptom Rating Scale [GSRS], Bristol Stool Form Scale [BSFS]] and Patient Health. The study used a human clinical study. The comparison condition was control condition or baseline measurements.
What Effects Did Molecular Hydrogen Have?
2.1.4.3 Hydrogen nanobubble water was obtained from Shinbiosis, Inc. 2.1.4.4 At room temperature (20 ± 3 °C), approximately 100 g of feces was added to 250 g of hydrogen nanobubble water and stirred with a magnetic stirrer (stirrer length: 3 cm) for approximately 90 min to prepare a suspension. This novel hydrogen nanobubble water-based FMT method was safe and effective, reducing both core and peripheral symptoms of ASD and suggesting broad benefits via the gut microbiota-brain axis.Clinical Trial Registration: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031230041.
Why These Findings Matter
These findings add human evidence supporting molecular hydrogen's therapeutic potential across the specific human outcomes evaluated in this study and contribute to the growing body of molecular-hydrogen research.
How Strong Is This Evidence?
This is human clinical evidence from a human clinical study. H2HUBB interprets the findings in the context of the study design, sample, comparator, and measured outcomes rather than using one publication as a verdict on hydrogen therapy.
Technical Study Details
H2HUBB classifies this publication as human clinical study with human clinical evidence. The research population or model was Secondary outcomes included sensory profile [Short Sensory Profile (SSP)], gastrointestinal symptoms [Gastrointestinal Symptom Rating Scale [GSRS], Bristol Stool Form Scale [BSFS]] and Patient Health. The reported sample size was 30. The study used a human clinical study.
Limitations and Safety
No separate limitations or safety findings were identified in the current-study source text available to H2HUBB.
Original Study and H2HUBB Research Context
H2HUBB presents this source-grounded research record as one contribution to the broader molecular-hydrogen evidence base.