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Rare sugar in the patient with autism

Safety and efficacy of rare sugar in the patient with autism spectrum disorder - SERPA

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180411
Enrollment
30
Registered
2019-03-22
Start date
2019-03-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Impairments in social and language skills.Obesty

Interventions

Short-term study: the real medicine (D-allulose) and placebo (D-glucose) is first administered to those assigned to group A and B for one month, respectively.After a washout period of one month, as a

Sponsors

Monden Yukifumi
Lead Sponsor
Yamagata Takanori
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. The diagnosis for ASD was made based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 2. Parents or legal guardians of the participant provide written informed consent for participation.

Exclusion criteria

Exclusion criteria: 1. Comorbid severe neurodegenerative, metabolic, and progressive disorder 2. Severe abnormalities of blood or electrocardiogram examination 3. Persistent diarrhea 4. Severe drug or food allergy 5. Those who changed one's medicine related to symptoms of ASD, treatment of liver dysfunction or cholesterolemia within three months 6. Responsible doctors judged a patient inappropriate for the trial

Design outcomes

Primary

MeasureTime frame
Adverse event: condition or frequency of stool, blood examination, weight loss, hypertension, fatigue, anxiety, dizziness, headache, edema.

Secondary

MeasureTime frame
Autistic symptom (DSM-5, PARS, CARS2, Sensory Profile, SCQ, SRS2), autistic associated symptom (ABC-J, RBS-R, Vineland2), circadian rhythm, endocrine and metabolic examination (oxytocin, GLP-1), brain function (eye tracker, etc), developmental or intellectual evaluation (WISC-IV, etc)

Contacts

Public ContactYukifumi Monden

Jichi Medical University Hospital

mon4441977319@jichi.ac.jp+81-285-58-7366

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026