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Effect of Probiotics (Vivomixx®) on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn

NCT02508844 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-23

No results posted yet for this study

Summary

The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight body composition of their infants.

Conditions

  • Pregnancy
  • Obesity
  • Gestational Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

Vivomixx®

probiotics intake (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery

DIETARY_SUPPLEMENT

Placebo

Four capsules/day from gestational age 14-20 until delivery. The placebo capsule contains microcrytalline cellulose, magnesium stearate and silicon dioxide.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Statens Serum Institut

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Andreas M Petersen, MD, PhD · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-01-31
Completion
2020-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT02508844 on ClinicalTrials.gov