Gestational Diabetes Mellitus in Pregnancy
Conditions
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
Interventions
DIETARY_SUPPLEMENTcapsule 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.
OTHERcapsule 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.
Sponsors
i-Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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: 1. Subjects currently enrolled in another clinical study 2. Subjects having finished another clinical study within the last 4 weeks before inclusion 3. Diabetes mellitus 4. Acute metabolic disorder interfering with glucose metabolism 5. Known cancer \< 5y ago 6. Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota 7. Anus praeter 8. Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product 9. 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 10. History of active hepatitis B and C 11. History of HIV infection 12. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.) 13. Major cognitive or psychiatric disorders 14. Present drug abuse or alcoholism, reformed alcoholic Legal incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed