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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987593
• Other study ID #: HND-IN-039
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Pregnant women:

1. Enrolled at Aarhus University Hospital

2. Singleton pregnancy

3. Age above 18 years at informed consent

4. Aim to give birth vaginally

5. Aim to breastfeed

6. No use of probiotics (contained in dietary supplements/ food) after written consent.

Infants:

1. Gestational age between 37-42 weeks

Exclusion Criteria:

Pregnant women • Use of immunosuppressant drugs.

Infants:

• None

Related Conditions & MeSH terms

• Gut Microbiome
• Infant Development

Intervention

Dietary Supplement:
• Probiotics
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

Locations

Country	Name	City	State
Denmark	Department of Gynaecology and Obstetrics	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Chr Hansen	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant gastrointestinal problems	Infants gastrointestinal problems will be assessed using the Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems (ROME IV)	28 days
Other	Infant stool frequency and consistency	Infants stool frequency and consistency will be assessed using Amsterdam Stool Chart	28 days
Other	Infant Reflux	Reflux will be assessed using the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)	28 days
Other	Adverse events	Any adverse events experienced by either mother or infant will be recorded during the entire study period	12 weeks
Primary	Recovery of study product in infant feces	Presence of at least one of the probiotic strains in infant feces using PCR	28 days after birth
Secondary	Recovery of study product in maternal feces	Presence of at least one of the probiotic strains in maternal feces using PCR	28 days
Secondary	Quantification of the microbiota in breastmilk	Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR	28 days after birth
Secondary	Quantification of the maternal vaginal microbiota	Characterization of the vaginal microbiota and recovery of probiotic strains using PCR	28 days