At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placebo-controlled Intervention Study for Maternal and Child Health
In Brief
A clinical study evaluating Comparison of probiotics, fish oil and their combination to placebo for Pregnancy and 9 related conditions. Completed, enrolled 439 participants across 2 sites.
Detailed Summary
A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery. The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated. Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.
Study Details
Timeline
Interventions
Double-blind randomized placebo controlled intervention