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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of the investigational product in the infant feces | Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR | 28 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Total fecal Bifidobacterium in infant fecal samples | Total fecal Bifidobacterium in infant fecal samples after 4 weeks supplementation Quantification of total Bifidobacterium will be determined by PCR. | Baseline, Day14, Day 28 |
| Characterization of the infant intestinal microbiota after 4 weeks supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Mothers fecal microbiota | Characterization of mother's microbiota from fecal samples will be assessed using sequencing to examine the microbiota for similarities with the infant | Baseline |
| Infant Gastrointestinal Problems |
Infants to be enrolled at birth.
Inclusion Criteria for Infants (study subjects)
Pregnant women:
Exclusion criteria for Infants (study subjects)
• Admission to the neonatal intensive care unit (NICU)
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| Name | Affiliation | Role |
|---|---|---|
| Lars Henning Pedersen, Professor | Department of Gynecology and Obstetrics, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaecology and Obstetrics | Aarhus | 8200 | Denmark |
To share IPD not decided yet
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Characterization of the infant intestinal microbiota after 4 weeks supplementation of the investigational product using sequencing |
| Baseline, Day 14, Day 28 |
| Adverse events (Safety) | Frequency and severity of adverse events | up to 6 weeks |
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
| 42 days |
| Stool frequency and consistency | Infant stool frequency and consistency will be measured using Amsterdam Stool Chart. | 42 days |
| Reflux | Reflux will be measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) | 42 days |
| Breastmilk microbiome | Microbiome of the breastmilk to be assessed using sequencing to explore a potential microbiota of the breastmilk | Baseline, Day 14, Day 28 |
| Mothers vaginal microbiota | Characterization of mother's vaginal microbiota will be assessed using sequencing to examine the microbiota for similarities with the infant | Baseline |
| D019602 |
| Food and Beverages |