Gut Microbiota
Conditions
Brief summary
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.
Detailed description
The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product. During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily. Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. 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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth
Sponsors
Aarhus University Hospital
Chr Hansen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 2 Months
Healthy volunteers
Yes
Inclusion criteria
Infants to be enrolled at birth. Inclusion Criteria for Infants (study subjects) * Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks * Birthweight more than 2500 g * No exposure to oral or intravenous antibiotics * No complications that need medical interventions (e.g. respiratory distress symptoms or infections) * Both legal guardians provided voluntary written informed consent on behalf of the infant Pregnant women: * Women age above 18 years at informed consent * Singleton pregnancy * Uncomplicated pregnancy * No use of medication * Aim to give birth vaginally and breastfeed * No use of probiotics during the last month before estimated birth and until six weeks postpartum * Provided voluntary written informed consent
Exclusion criteria
for Infants (study subjects) • Admission to the neonatal intensive care unit (NICU)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of the investigational product in the infant feces | 28 days after birth | Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total fecal Bifidobacterium in infant fecal samples | Baseline, Day14, Day 28 | Total fecal Bifidobacterium in infant fecal samples after 4 weeks supplementation Quantification of total Bifidobacterium will be determined by PCR. |
| Characterization of the infant intestinal microbiota after 4 weeks supplementation | Baseline, Day 14, Day 28 | Characterization of the infant intestinal microbiota after 4 weeks supplementation of the investigational product using sequencing |
| Adverse events (Safety) | up to 6 weeks | Frequency and severity of adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant Gastrointestinal Problems | 42 days | Infant Gastrointestinal Problems will be measured using ROME IV Diagnostic Questionnaires for Pediatric Functional Gastrointestinal Disorders for Neonates and Toddlers: Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems |
| Reflux | 42 days | Reflux will be measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) |
| Stool frequency and consistency | 42 days | Infant stool frequency and consistency will be measured using Amsterdam Stool Chart. |
| Breastmilk microbiome | Baseline, Day 14, Day 28 | Microbiome of the breastmilk to be assessed using sequencing to explore a potential microbiota of the breastmilk |
| Mothers vaginal microbiota | Baseline | Characterization of mother's vaginal microbiota will be assessed using sequencing to examine the microbiota for similarities with the infant |
| Mothers fecal microbiota | Baseline | Characterization of mother's microbiota from fecal samples will be assessed using sequencing to examine the microbiota for similarities with the infant |
Countries
Denmark
Outcome results
None listed