Impact of Oral Probiotic Blend on Pregnancy Outcome

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli
* Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women aged > 18 years in the < 14 week of pregnancy willing to consume the study product during pregnancy ( V1 to delivery) willingness to abstain from probiotic food and supplements containing probiotics written informed consent Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from enrollment in the study: Subjects currently enrolled in another clinical study Subjects having finished another clinical study within the last 4 weeks before inclusion Diabetes mellitus Acute metabolic disorder interfering with glucose metabolism Known cancer < 5y ago Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota Anus praeter Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product Any disease or condition which might significantly compromise the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system History of active hepatitis B and C History of HIV infection Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.) Major cognitive or psychiatric disorders Present drug abuse or alcoholism, reformed alcoholic Legal incapacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: verum<br>probiotic bland with 5 different lactobacilli | Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli<br>* n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.<br>* Other names: verum;|
| Placebo Comparator: placebo<br>Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. | Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.<br>* n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |