Impact of Oral Probiotic Blend on Pregnancy Outcome
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|ClinicalTrials.gov Identifier: NCT04009889|
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus in Pregnancy||Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||May 30, 2020|
Active Comparator: verum
probiotic bland with 5 different lactobacilli
Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli
n=81 women (verum) starts befor end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Other Name: verum
Placebo Comparator: placebo
Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
n=81 women (placebo) starts befor end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Other Name: placebo
- HOMA-IR value in week 24-28 [ Time Frame: measurement between 24-28 week of pregnancy ]HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
- HOMA-IR value in week 36-40 [ Time Frame: measurement between 36-40 week of pregnancy ]HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009889
|Contact: Seema Mody||+1(860)email@example.com|
|Contact: Linnerth Barbara, PhD||+43/1/2350780||linnerth@HSO.at|
|Principal Investigator:||Christiane Laue, MD||Clinical Research Center Kiel GmbH, Germany|