Status:
COMPLETED
Impact of Oral Probiotic Blend on Pregnancy Outcome
Lead Sponsor:
i-Health, Inc.
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 Lbv1...
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 criter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2020
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04009889
Start Date
April 5 2018
End Date
June 12 2020
Last Update
February 9 2021
Active Locations (1)
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1
Clinical Research Center Kiel GmbH
Kiel, Schleswig-Holstein, Germany, D-24118