Dupont Applied Biosciences

Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal social and communicative milestones, as well as restrictive and/or repetitive patterns of behavior which lead to significant functional challenges impacting individuals throughout their lifespan. There are major shortcomings in the existing pharmacological interventions; they are of limited efficacy, target a subset of problematic behaviors, and fail to improve social cognition. To overcome these limitations and improve outcomes, the investigators study the use of neurostimulation to mitigate the social and cognitive manifestations of ASD.

General adult healthy pregnant females in total 400, as well as their infants will be recruited. It is expected 67% will be vaginally delivered and 33% will be C Section deliveries. It is expected that of these groups that 40% of these women will be treated with antibiotics during their pregnancy. All C Section women (including emergency C Section) will be treated with IV Cefazolin at the time of incision, in theatre, to prevent internal wound infection.
Primary objective The effect of maternal antibiotic administration during pregnancy upon the development of the intestinal microbiota until the age of two years; of C-section delivered infants compared to C-section delivered infants born to non-antibiotic treated pregnant women. To develop a cohort of vaginally delivered infants to isolate the 'missing microbes' (intestinal) in the groups above.
Secondary objective
The effect of maternal antibiotics on the developing infant by:
Anthropometric assessment: Body weight and Body length
Bayley scale of infant development test at age 2 years
Ancillary
To isolate and characterise bacterial strains from fresh healthy infant faeces that are altered in the stools from C-section delivered and antibiotic treated infants and compared to vaginally delivered infants.
The effect of maternal antibiotic treatment on the human milk microbiome during lactation
Stress hormone levels of mothers and infants
Mental health questionnaire of mothers
Food frequency questionnaire of mothers Exploratory
To identify bacterial strains that can be further developed into probiotic products to help replenish depleted microbiota in the infant gut, born by C Section and or treated with antibiotics

The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.