Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2018-04-05
2020-06-12
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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verum
probiotic bland with 5 different lactobacilli
capsule 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.
placebo
Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
capsule 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.
Interventions
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capsule 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.
capsule 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
FEMALE
Yes
Sponsors
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i-Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christiane Laue, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center Kiel GmbH, Germany
Locations
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Clinical Research Center Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Countries
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References
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Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.
Other Identifiers
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HSO-PregO-2018
Identifier Type: -
Identifier Source: org_study_id
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