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Completed

NCT Number: NCT04987593

Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics

A monocenter, open label pilot study in pregnant women and their offspring with at least four weeks prenatal and four weeks postnatal maternal intervention with a study product consisting of four different food constituents.

The study will investigate the effect of maternal supplementation with the food constituents on the recovery of the constituents in the maternal and infant feces, the microbiota in both mother and infant and potential transmission routes from mother to infant.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynaecology and Obstetrics

Aarhus, 8200, Denmark

About this study

Pregnant women will be recruited at the ordinary midwife visit in gestational week 28. The intervention will begin in gestational week 33+0 to ensure at least four weeks prenatal intervention before expected birth.

The study will be conducted in four phases. First phase is the run-in phase. The second phase is the prenatal intervention period from gestational week 33+0 until birth. Third phase is the postnatal intervention period, from birth until four weeks postnatal. The last phase is a two weeks follow-up period without any intake of the investigational product.

Infant stool samples, as well as maternal breast milk samples, stool and urine samples and samples from vagina will be collected on multiple occasions during the study. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant women:

  • Enrolled at Aarhus University Hospital
  • Singleton pregnancy
  • Age above 18 years at informed consent
  • Aim to give birth vaginally
  • Aim to breastfeed
  • No use of probiotics (contained in dietary supplements/ food) after written consent.

Infants:

  • Gestational age between 37-42 weeks

Exclusion criteria

Pregnant women • Use of immunosuppressant drugs.

Infants:

  • None

Treatment and study plan

Probiotics

Dietary Supplement

Once a day daily intake of probiotics, at least for 28 consecutive days before giving birth and for at least 28 consecutive days after giving birth

Primary outcomes

  1. Recovery of study product in infant feces

    Time frame: 28 days after birth

    Presence of at least one of the probiotic strains in infant feces using PCR

Secondary outcomes

  1. Recovery of study product in maternal feces

    Time frame: 28 days

    Presence of at least one of the probiotic strains in maternal feces using PCR

  2. Quantification of the microbiota in breastmilk

    Time frame: 28 days after birth

    Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR

  3. Quantification of the maternal vaginal microbiota

    Time frame: 28 days

    Characterization of the vaginal microbiota and recovery of probiotic strains using PCR

Other outcomes

  1. Infant gastrointestinal problems

    Time frame: 28 days

    Infants gastrointestinal problems will be assessed using the Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems (ROME IV)

  2. Infant stool frequency and consistency

    Time frame: 28 days

    Infants stool frequency and consistency will be assessed using Amsterdam Stool Chart

  3. Infant Reflux

    Time frame: 28 days

    Reflux will be assessed using the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)

  4. Adverse events

    Time frame: 12 weeks

    Any adverse events experienced by either mother or infant will be recorded during the entire study period

Sponsors and collaborators

Lead sponsor

Chr Hansen

Industry

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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