Probiotics for children with autism and persistent gut symptoms
Probiotics for Autism Spectrum Disorders: a Randomized Controlled Trial (The PASD Study)
This trial will try the probiotic Lactobacillus rhamnosus GG versus a placebo in children aged 4–12 with confirmed autism and persistent functional gastrointestinal symptoms (GSI ≥7) to see if it improves their gut symptoms and related behavior.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT07345585 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, placebo-controlled trial at the University of Naples Federico II enrolling children aged 4–12 with confirmed autism spectrum disorder and functional gastrointestinal disorders lasting at least 3 months with a GSI ≥7. Participants are randomized to receive Lactobacillus rhamnosus GG or an identical placebo, with exclusions for recent antibiotics or pre/pro/synbiotic use and for other chronic medical conditions. The trial will track changes in gastrointestinal symptom severity and collect behavioral and microbiome-related data to explore gut–brain links. The goal is to see whether probiotic supplementation reduces GI symptoms and has any associated effects on behavior.
Who should consider this trial
Good fit: Children aged 4–12 with a confirmed diagnosis of autism spectrum disorder and persistent functional gastrointestinal symptoms (GSI ≥7) for at least 3 months who have not used antibiotics or pre/pro/synbiotics in the prior 6 months and have no major chronic medical conditions are ideal candidates.
Not a fit: Children with other chronic medical conditions, recent use of antibiotics or probiotic products, uncertain diagnoses, symptoms under 3 months, or those outside the 4–12 age range are unlikely to benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, the probiotic could reduce chronic GI symptoms in children with ASD and potentially ease related behavioral issues, improving daily comfort and functioning.
How similar studies have performed: Small clinical and preclinical studies have suggested microbiome-targeted treatments can improve GI symptoms and sometimes behavior in ASD, but evidence remains limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children aged 4-12 years * children of both sex * children with a sure diagnosis of ASD and presence of FGIDs with a GSI ≥7 from at least 3 months. Exclusion Criteria: * children aged \<4 or \>12 years * uncertain ASD and/or FGIDs diagnosis * FGIDs duration lasting \<3 months * concomitant presence of other chronic conditions (adverse food reactions; genetic and metabolic disorders; malformations of GI, respiratory or urinary tract; neurologic diseases; immunodeficiencies; diabetes; cardiovascular diseases; autoimmune diseases; chronic infections; chronic respiratory, GI or urinary tract diseases; obesity; tumors; malnutrition). * use of antibiotics and/or pre-/pro-/ synbiotics during the 6 months prior to enrolment * participation into other clinical trials during the last 12 months.
Where this trial is running
Naples
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.