Adults 2 to 11, any sex, with Autism. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Stool Microbiota Composition Change During Prebiotic Only TreatmentPrimary· Five weeks
The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before prebiotic only treatment to after prebiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella ("Prevotella"), a community high in Bifidobacterium ("Bifidobacterium"), a community high in Bacteroides ("Bacteroides"), and a mixed community ("Mixed") that did not fall into one of the other three enterotypes bu
Group
Value
95% CI
Prebiotic Only First, Then Synbiotic
2
Synbiotic First, Then Prebiotic Only
3
Prebiotic Only First, Then Synbiotic
1
Synbiotic First, Then Prebiotic Only
0
Prebiotic Only First, Then Synbiotic
1
Synbiotic First, Then Prebiotic Only
0
Prebiotic Only First, Then Synbiotic
0
Synbiotic First, Then Prebiotic Only
1
Stool Microbiota Composition Change During Synbiotic TreatmentPrimary· Five weeks
The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before synbiotic treatment to after synbiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella ("Prevotella"), a community high in Bifidobacterium ("Bifidobacterium"), a community high in Bacteroides ("Bacteroides"), and a mixed community ("Mixed") that did not fall into one of the other three enterotypes but ins
Group
Value
95% CI
Prebiotic Only First, Then Synbiotic
4
Synbiotic First, Then Prebiotic Only
2
Prebiotic Only First, Then Synbiotic
0
Synbiotic First, Then Prebiotic Only
1
Prebiotic Only First, Then Synbiotic
0
Synbiotic First, Then Prebiotic Only
1
Serum Immune Profile Change During Prebiotic Only TreatmentSecondary· Five weeks
Luminex technology will be used to determine a serum immune profile of each participants in response to the study supplement. This profile included assessment of change in percentage of stimulated CD4+ T cells producing intracellular IL-13 before and after Synbiotic treatment ("Post-Synbiotic % IL-13"), and assessment of change in percentage of stimulated CD8+ T cells producing TNF-alpha before and after Prebiotic Only treatment ("Post-Prebiotic % TNF-alpha"). Results are reported here for all subjects regardless of treatment order assignment. Decrease in inflammatory cytokines IL-13 and TNF-a
Post-Synbiotic % IL-13
Group
Value
95% CI
All Subjects
-0.8
-2.073 – -0.524
Post-Prebiotic % TNF-alpha
Group
Value
95% CI
All Subjects
-7.9
-14.375 – -1.425
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected from time of consent through end-of-treatment (12 weeks total)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine the tolerability of dietary supplements and if these supplements can promote a healthy bacterial environment in the intestines of children with autism spectrum disorders and gastrointestinal complaints.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07515443 — The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health: A Randomized Double-
· NA
· completed
NCT06901739 — Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.
· NA
· recruiting
NCT06396689 — NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
· NA
· not yet recruiting
NCT06300060 — Synbiotic Supplementation in Cyclists
· NA
· completed
NCT06722443 — Impact of Nutritional Intervention With Probiotics and Prebiotics on Obesity.
· NA
· enrolling by invitation
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Davis
Last refreshed: 1 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02086110.