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
capsule containing a probiotic blend of 5 different Lactobacilli
+ capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
Prevention Study
Summary
Study start date: April 5, 2018
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.170 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Clinical Research Center Kiel GmbH
Kiel, GermanyOpen Clinical Research Center Kiel GmbH in Google Maps