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Impact of Oral Probiotic Blend on Pregnancy Outcome

NCT04009889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2021-02-09

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • i-Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Christiane Laue, MD · Clinical Research Center Kiel GmbH, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2020-02-20
Completion
2020-06-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009889 on ClinicalTrials.gov