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PregnancyPhase 4POPNCT02508844

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

A Phase 4 study testing Vivomixx® in people with Pregnancy and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Obesity, Gestational Diabetes Mellitus
What is being tested?
Vivomixx®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteDenmark
Study dates
Apr 2015to Mar 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hvidovre University Hospital

    Hvidovre, Copenhagen, 2650

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
Vivomixx®, Placebo
Keywords
Probiotics, Vivomixx®, Microbiota
Medical subject headings
Obesity, Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivomixx®Dietary supplement

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

  • PlaceboDietary supplement

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

Study groups in NCT02508844
Study groupRoleWhat they receive
Vivomixx®ExperimentalBifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus
Receives: Dietary Supplement: Vivomixx®
PlaceboPlacebo comparatormicrocrytalline cellulose, magnesium stearate and silicon dioxide.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational weight gain

    weight at gestational age 36-37-weeks minus self-reported pre-pregnancy weight

    Measured: week 36-37 of pregnancy

  2. Change in glucose levels (Oral glucose tolerance test)

    Measured: baseline (week 14-20) and 27-30 of pregnancy

Secondary outcomes (3)

  1. Change in fecal microbiota

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

  2. Amount of fat tissue in the newborn infant

    examined by a DEXA-scanning

    Measured: at birth

  3. Change in HbA1c

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJan 2018
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02508844
Sponsor's protocol ID
H-2-2014-076
Acronym
POP
Status last verified
Mar 2020
First submitted
11 May 2015
Last updated
23 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37580231

  • 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.

    PubMed 32617453

  • 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.

    PubMed 27724923

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vivomixx® in people with Pregnancy and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain (time frame: week 36-37 of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02508844, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.

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