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Take a daily supplement to help with digestive problems and autism symptoms | stella

Back to Autism Spectrum Disorder (ASD) trials

Recruiting

Testing a supplement to help digestive and behavioral symptoms in autistic children

Plain-English translation of NCT06514573 on ClinicalTrials.gov ↗ · Source last updated May 2025 · Translation generated July 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether sodium butyrate, a natural compound that may help support gut health, can improve digestive problems and behavioral symptoms in young children with autism spectrum disorder. Half of the children will receive the medication daily, and half will receive a placebo (a dummy treatment that looks identical). All children will continue their regular autism care.

Many children with autism also struggle with digestive problems that can make their behavior and sleep worse. Doctors believe that this medication may help by supporting the gut's natural bacteria and reducing inflammation, but this hasn't been proven yet in children with autism.

Do you qualify?

You likely qualify if…

you are the parent or guardian of a child between ages 3 and 6
your child has been diagnosed with autism spectrum disorder
your child has had digestive problems for at least 3 months

You likely don't qualify if…

your child is already older than 6 years old
your child has other chronic health conditions like metabolic disorders, immune problems, or diabetes
your child has taken antibiotics or probiotics in the last 6 months before enrollment
your child is severely malnourished or has obesity
your child participated in another clinical trial in the past 12 months

What participation looks like

Your child will take a daily powder supplement (either the medication or placebo) mixed in a sachet at home, based on their body weight. You'll also bring your child to visits at one of the study centers so doctors can check on their digestive and behavioral symptoms. The study will track how your child responds over time while continuing all their regular autism treatments and care.

AI-generated summary from trial data · Jul 11, 2026 · Not medical advice

Trial locations(3 sites)

Italy

Azienda Ospedaliera Universitaria Federico II, Naples

Policlinico Tor Vergata Hospital, Rome

Istituto Superiore di Sanità, Rome

Key details

Sponsor

Istituto Superiore di Sanità

Collaborators

University of Rome Tor Vergata, Federico II University

Enrollment target

~128 participants

Started

May 2025

Primary completion

July 2026

This trial's estimated completion date has passed — the record may not be fully up to date.

Age range

3 Years – 6 Years

Last updated on clinicaltrials.gov in May 2025.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

Maria Luisa Scattoni, Ph.D.

Istituto Superiore di Sanità

Interested in joining?

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View full record on ClinicalTrials.gov