The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation.
Pregnant women aged \> 18 years in the \< 14th week of pregnancy willing to consume the study product once daily starting the day after V1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study. After enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo. The study population will be recruited in a screening examination ( G1 ) by gynaecologists from Kiel area. Primary target parameter of the study : HOMA-IRa value in week 24-28 (V2), which is based on glucose and insulin measures during the second oral glucose tolerance test (OGTT) Secondary target parameters : HOMA-IR value in week 36-40 , Alteration (V2 - V1) Δ HOMA-IR, Alteration (V2 - V1) Δ QUICKI
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
170
n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Clinical Research Center Kiel GmbH
Kiel, Schleswig-Holstein, Germany
HOMA-IR value in week 24-28
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
Time frame: measurement between 24-28 week of pregnancy
HOMA-IR value in week 36-40
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
Time frame: measurement between 36-40 week of pregnancy
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