NCT04009889

Impact of Oral Probiotic Blend on Pregnancy Outcome

Double Blind,Randomized, Controlled Trial on Impact of Oral Probiotic Blend ( Lactobacillus Rhamnosus GG, L. Crispatus LBV88, L. Rhamnosus LBV96, L.Jensenii LBV116 and L. Gasseri LBV150 ) on Pregnancy Outcome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: i-Health, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	capsule containing a probiotic blend of 5 different Lactobacilli	n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
OTHER	capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.	n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.

Timeline

• Start date: 2018-04-05
• Primary completion: 2020-02-20
• Completion: 2020-06-12
• First posted: 2019-07-05
• Last updated: 2021-02-09

Locations

1 site across 1 country: Germany