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

Launched by ISTITUTO SUPERIORE DI SANITÀ · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called butyrate on children aged 3 to 6 years who have Autism Spectrum Disorder (ASD) and gastrointestinal issues. ASD is a condition that affects communication and behavior, and many children with ASD also experience functional gastrointestinal disorders (FGIDs), which can cause stomach problems without any clear medical reason. The researchers want to see if taking butyrate for 16 weeks can help improve both the gastrointestinal symptoms and the overall behavior and well-being of these children. They will also look at how butyrate affects the gut bacteria and immune responses in the body.

To participate in this study, children must be between 3 and 6 years old, have a diagnosis of ASD, and have FGIDs that have lasted for more than three months. Some children may not be eligible if they have certain other health conditions or have recently taken medications that affect their digestive system. While the study is not yet recruiting participants, families can expect that if their child is enrolled, they will receive either the butyrate supplement or a placebo (a non-active version) for the trial period, and their child's symptoms and behaviors will be closely monitored throughout the study. Ultimately, the researchers hope that this treatment will improve the quality of life for both the children and their families.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • children aged 3-6 years
• • both sexes
• • ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) \>7 from \> 3 months)
• Exclusion Criteria:
• • age 6 years
• • uncertain FGIDs diagnoses
• • FGIDs symptoms duration \<3 months
• • concomitant presence of other chronic condition (adverse food reactions, metabolic disorders, infections)
• • malformation and Gi or urinary tracts chronic diseases
• • immunodeficiencies
• • diabetes
• • neurologic/cardiovascular/autoimmune diseases
• • obesity
• • malnutrition
• • antibiotics and/or pre-/pro-/synbiotics use 6 months prior to enrollment
• • last 12 months participation into other clinical trials