Impact of Oral Probiotic Blend on Pregnancy Outcome
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Interventions
- Dietary Supplement: capsule containing a probiotic blend of 5 different LactobacilliOther: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
- Registration Number
- NCT04009889
- Lead Sponsor
- i-Health, Inc.
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 170
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description verum capsule containing a probiotic blend of 5 different Lactobacilli probiotic bland with 5 different lactobacilli placebo capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
- Primary Outcome Measures
Name Time Method HOMA-IR value in week 36-40 measurement between 36-40 week of pregnancy HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
HOMA-IR value in week 24-28 measurement between 24-28 week of pregnancy HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Center Kiel GmbH
🇩🇪Kiel, Schleswig-Holstein, Germany