Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders

NARecruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

November 30, 2026

Conditions
Autism Spectrum Disorder (ASD)
Interventions
DIETARY_SUPPLEMENT

Sodium Butyrate

Daily supplementation with 1 sachet per day for 16 weeks

DIETARY_SUPPLEMENT

Placebo (cornstarch)

Daily supplementation with 1 sachet per day for 16 weeks

Trial Locations (3)

80131

RECRUITING

Azienda Ospedaliera Universitaria Federico II, Naples

00133

RECRUITING

Policlinico Tor Vergata Hospital, Rome

00161

RECRUITING

Istituto Superiore di Sanità, Rome

All Listed Sponsors
collaborator

University of Rome Tor Vergata

OTHER

collaborator

Federico II University

OTHER

lead

Istituto Superiore di Sanità

OTHER

NCT06514573 - Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders | Biotech Hunter | Biotech Hunter