Evidence map›Paper›PMID 27724923›Full record

Trial reportTrials2016

Effects of probiotics (Vivomixx®) in obese pregnant women and their newborn: study protocol for a randomized controlled trial.

Sofie Ingdam Halkjaer, Lisbeth Nilas, Emma Malchau Carlsen, Dina Cortes, Thórhallur Ingi Halldórsson, Sjúrdur Frodi Olsen, Anders Elm Pedersen, Karen Angeliki Krogfelt, Andreas Munk Petersen

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02508844 (The POP-study), which is not on this map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02508844 phase4completednot on this map

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®

TypeinterventionalSponsorHvidovre University HospitalRan2015 to 2020Enrolled50ConditionsPregnancy, Obesity, Gestational Diabetes MellitusArmsVivomixx®, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Probiotics for preventing gestational diabetes.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Pooled it
  6. Trial
  7. Nutraceuticals in Pregnancy: A Special Focus on Probiotics.International journal of molecular sciences · 2024
    Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. The impact of maternal obesity on childhood neurodevelopment.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Sofie Ingdam HalkjaerDepartment of Gastroenterology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.
Lisbeth NilasDepartment of Obstetrics and Gynecology, Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark.
Emma Malchau CarlsenDepartment of Pediatrics, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.
Dina CortesFaculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Thórhallur Ingi HalldórssonDepartment of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
Sjúrdur Frodi OlsenDepartment of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
Anders Elm PedersenDepartment of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Karen Angeliki KrogfeltDepartment of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, Denmark.
Andreas Munk PetersenDepartment of Gastroenterology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark. andreas.munk.petersen@regionh.dk.
Copenhagen University Hospital · DKStatens Serum Institut · DKUniversity of Copenhagen · DKUniversity of Iceland · IS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaternal obesity is associated with increased risks of adverse pregnancy-related complications and outcomes for both mothers and infants. Overweight and obese women have an increased risk of pregnancy-induced hypertension, preeclampsia and gestational diabetes mellitus (GDM). Infant Body Mass index (BMI) and the risk of obesity in adulthood are related to maternal gestational weight gain (GWG). Preventive lifestyle and dietary interventions are time-consuming and do not always reduce GWG or the risk of maternal pregnancy complications. Recent research has indicated that the gut microbiota may play a significant role in the development of obesity. Some studies have indicated that the daily consumption of probiotics may reduce the risk of preeclampsia, maintain serum insulin levels and reduce the frequency of GDM in pregnant women. The aims of this study are to investigate whether daily probiotic supplements in obese women during pregnancy can limit gestational weight gain, improve glucose homeostasis and thereby improve maternal, fetal and infant health outcomes.

methodsA pilot study including 50 obese pregnant nulliparous women with a prepregnancy BMI of between 30 and 35 kg/m DISCUSSION: We expect to find alterations in the metabolic profiles, microbiota and possibly pregnancy outcomes. From a clinical point of view the effects of Vivomixx® could control weight gain and reduce complications during pregnancy by inducing changes in the gut microbiota. Furthermore, this intervention during pregnancy could influence the infant's microbiota, which could have important implications for infant development and health.

trial registrationClincalTrials.gov Identifier: NCT02508844 , registered on 11 May 2015.

Indexed as

Dietary SupplementsPregnancy ComplicationsBlood GlucoseDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansInfant, NewbornObesityPilot ProjectsPregnancyProbioticsSample SizeWeight GainBlood GlucoseGestational diabetes mellitusMicrobiotaObesityPregnancyProbioticsStudy protocolVivomixx®

Identifiers

PMID27724923
PMCPMC5057415
OpenAlexW2530129114

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.