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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum | Active Comparator | probiotic bland with 5 different lactobacilli |
|
| placebo | Placebo Comparator | Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsule containing a probiotic blend of 5 different Lactobacilli | Dietary Supplement | n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR value in week 24-28 | HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance | 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 | measurement between 36-40 week of pregnancy |
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Inclusion Criteria:
Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from enrollment in the study:
pregnant women aged > 18 years in the < 14 week of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Laue, MD | Clinical Research Center Kiel GmbH, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center Kiel GmbH | Kiel | Schleswig-Holstein | D-24118 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33870484 | Derived | Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3. |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
| C031183 | stearic acid |
| D012822 | Silicon Dioxide |
| ID | Term |
|---|---|
| D008903 | Minerals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
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|
| capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. | Other | n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery. |
|
|
| D017655 |
| Silicon Compounds |