Department of Gynaecology and Obstetrics
Aarhus, 8200, Denmark
NCT Number: NCT04987593
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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Notify Me18 year and older
Female
Interventional
Not applicable
Aarhus, 8200, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Pregnant women:
Infants:
Exclusion criteria
Pregnant women • Use of immunosuppressant drugs.
Infants:
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
Time frame: 28 days after birth
Presence of at least one of the probiotic strains in infant feces using PCR
Time frame: 28 days
Presence of at least one of the probiotic strains in maternal feces using PCR
Time frame: 28 days after birth
Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR
Time frame: 28 days
Characterization of the vaginal microbiota and recovery of probiotic strains using PCR
Time frame: 28 days
Infants gastrointestinal problems will be assessed using the Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems (ROME IV)
Time frame: 28 days
Infants stool frequency and consistency will be assessed using Amsterdam Stool Chart
Time frame: 28 days
Reflux will be assessed using the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)
Time frame: 12 weeks
Any adverse events experienced by either mother or infant will be recorded during the entire study period
Chr Hansen
Industry
Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study
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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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