Trial Outcomes & Findings for Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder (NCT NCT03514784)

Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder

Infection will be determined by clinical observations and temperature measurements made during the study period, as well as complete metabolic panel, complete blood count, and C-reactive protein (CRP) blood testing.

Tolerance will be determined by assessment of symptoms, which will be monitored at clinical research center visits, as well as ability to remain on the treatment.

Toxicity will be determined by assessment of electrolyte status, renal function \[blood urea nitrogen (BUN) and creatinine (Cr), hepatic toxicity \[transaminases (AST, ALT) and total bilirubin\], and hematologic status \[CBC to measure hemoglobin and absolute neutrophil count\].

Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the and the Social Responsiveness Scale-2 (SRS-2) pre and post treatment.

Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the Aberrant Behavior Checklist (ABC)-2 pre and post treatment

GI symptoms will be measured by the GI Severity Index.

Plasma S100A9 will indicate GI and systemic levels of inflammation. S100A9 is a damage-associated molecular pattern molecule (DAMP) released by granulocytes, which is reportedly elevated 2-fold in plasma of children with ASD.

Biological change in fecal calprotectin levels. FC is a highly accurate fecal marker of inflammation.

Plasma zonulin, a marker for intestinal permeability ("leaky gut"), which is often associated with inflammation.

IL-8 can be an indicator of gut inflammation; it released from the intestinal epithelial cells during inflammation.

Using 16S rDNA analysis, this will determine microbial alpha and beta diversity and distribution of the major taxa before and after probiotic treatment.

This will determine levels of metabolic markers which are reported to be abnormal in autism: fecal amino acids, ammonia, short chain fatty acids (SCFA), and phenols.