NCT02508844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

May 11, 2015

Last Update Submit

March 20, 2020

Conditions

PregnancyObesityGestational Diabetes Mellitus

Keywords

ProbioticsVivomixx®Microbiota

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change in fecal microbiota

    baseline (week 14-20) and week 36-37 of pregnancy

  • Amount of fat tissue in the newborn infant

    at birth

  • Change in HbA1c

    baseline (week 14-20) and week 36-37 of pregnancy

Study Arms (2)

Vivomixx®

EXPERIMENTAL

Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus

Dietary Supplement: Vivomixx®

Placebo

PLACEBO COMPARATOR

microcrytalline cellulose, magnesium stearate and silicon dioxide.

Dietary Supplement: Placebo

Interventions

Vivomixx®DIETARY_SUPPLEMENT

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

Vivomixx®
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy at \> 20 weeks gestation at recruitment
  • Pre-gestational diabetes or other serious diseases
  • Multiple pregnancy
  • Previous bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (3)

  • Halkjaer SI, de Knegt VE, Kallemose T, Jensen JB, Cortes D, Gluud LL, Wewer Albrechtsen NJ, Petersen AM. No effect of multi-strain probiotic supplementation on metabolic and inflammatory markers and newborn body composition in pregnant women with obesity: Results from a randomized, double-blind placebo-controlled study. Nutr Metab Cardiovasc Dis. 2023 Dec;33(12):2444-2454. doi: 10.1016/j.numecd.2023.07.030. Epub 2023 Jul 28.

    PMID: 37580231DERIVED

  • 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.

    PMID: 32617453DERIVED

  • 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.

    PMID: 27724923DERIVED

MeSH Terms

Conditions

ObesityDiabetes, Gestational

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Andreas M Petersen, MD, PhD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, clinical associate professor, Ph.D.

Study Record Dates

First Submitted

May 11, 2015

First Posted

July 27, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2018

Study Completion

March 1, 2020

Last Updated

March 23, 2020

Record last verified: 2020-03

Locations

DK(1)