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

The POP-study: Effect of Probiotics on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn - a Randomized, Double-blind Placebo Controlled Trial With Vivomixx®

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Pregnancy; Gestational Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Vivomixx®; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivomixx®; Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus	Dietary supplement: Vivomixx®; probiotics intake (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery
Placebo Comparator: Placebo; microcrytalline cellulose, magnesium stearate and silicon dioxide.	Dietary supplement: Placebo; Four capsules/day from gestational age 14-20 until delivery. The placebo capsule contains microcrytalline cellulose, magnesium stearate and silicon dioxide.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen; Statens Serum Institut
• Investigators: Principal Investigator: Andreas M Petersen, MD, PhD, Hvidovre University Hospital

Publications and helpful links

General Publications

• Halkjaer SI, de Knegt VE, Lo B, Nilas L, Cortes D, Pedersen AE, Mirsepasi-Lauridsen HC, Andersen LO, Nielsen HV, Stensvold CR, Johannesen TB, Kallemose T, Krogfelt KA, Petersen AM. Multistrain Probiotic Increases the Gut Microbiota Diversity in Obese Pregnant Women: Results from a Randomized, Double-Blind Placebo-Controlled Study. Curr Dev Nutr. 2020 May 27;4(7):nzaa095. doi: 10.1093/cdn/nzaa095. eCollection 2020 Jul.
• Halkjaer SI, Nilas L, Carlsen EM, Cortes D, Halldorsson TI, Olsen SF, Pedersen AE, Krogfelt KA, Petersen AM. Effects of probiotics (Vivomixx(R)) in obese pregnant women and their newborn: study protocol for a randomized controlled trial. Trials. 2016 Oct 11;17(1):491. doi: 10.1186/s13063-016-1617-5.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Microbiota; Probiotics; Vivomixx®
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: H-2-2014-076