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

Phase 4

Completed

• Conditions: Gestational Diabetes Mellitus; Obesity; Pregnancy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vivomixx®

• Registration Number: NCT02508844
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Accumulating evidence indicates that the gut microbiota plays a significant role in obesity and because the "ideal" composition of the gut microbiota remains poorly understood, modulation of the gut microbiota composition represents a potentially attractive treatment option against excessive gestational weight gain and adverse outcomes for obese pregnant women and their newborn. Dietary supplements in the form of probiotics could be an efficient treatment for controlling weight gain in pregnancy by inducing changes in the gut microbiota and could have influence on infant's microbiota, which could have important implications for infant development and health.

A pilot study including 50 obese pregnant nulliparous with BMI between 30-35 kg/m2 will, after accepting participation, be randomized to receive daily placebo or probiotics (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery. The infants will be followed until 9 months of age. Shortly after birth, tissue composition will be measured in the infants by DEXA-scanning. The women will be monitored by weight, blood-, fecal- and urine samples, diet questionnaires and hospital record review. Vivomixx® is a probiotic mixture of 8 probiotic strains, (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus).

This is the first pilot study in which the probiotic Vivomixx® are added in a randomized fashion to the standard of care in obese pregnant women. 50 pregnant women are planned to be included. The aim of this group size is to clarify the feasibility, compliance and to estimate parameters such as the standard deviation which will be used in a sample size calculation for a full-scale trial.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-07-24
• Study First Posted: 2015-07-27
• Primary Completion: 2018-01
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• BMI ≥ 30 and ≤35 kg/m2- calculated from pre-pregnancy weight
• Primiparous singleton pregnancy
• Able to read and speak Danish
• Normal ultrasound scan of the fetus at gestational age 12-14
• Oral glucose tolerance test at gestational age 14-20

Exclusion Criteria

• Pregnancy at > 20 weeks gestation at recruitment
• Pre-gestational diabetes or other serious diseases
• Multiple pregnancy
• Previous bariatric surgery
• Ingestion of probiotics < 1 month before the inclusion or ingestion of other kinds of probiotics than the study probiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	microcrytalline cellulose, magnesium stearate and silicon dioxide.
Vivomixx®	Vivomixx®	Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	week 36-37 of pregnancy	weight at gestational age 36-37-weeks minus self-reported pre-pregnancy weight
Change in glucose levels (Oral glucose tolerance test)	baseline (week 14-20) and 27-30 of pregnancy

Secondary Outcome Measures

Name	Time	Method
Change in fecal microbiota	baseline (week 14-20) and week 36-37 of pregnancy
Amount of fat tissue in the newborn infant	at birth	examined by a DEXA-scanning
Change in HbA1c	baseline (week 14-20) and week 36-37 of pregnancy

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark