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| ID | Type | Description | Link |
|---|---|---|---|
| H-24073138 | Other Identifier | Ethics Committee Case number |
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| Name | Class |
|---|---|
| Chr Hansen | INDUSTRY |
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The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.
The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Probiotic Dietary supplement |
|
| Placebo | Placebo Comparator | Identical looking placebo consisting of maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Other | Given daily from enrollement to 28 days of life |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of the probiotic strain in newborn/infant fecal samples | Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR. | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Infant fecal pH | Changes in Fecal pH measured in fecal water from fecal samples. | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks |
| Total abundance of bifidobacteria | Abundance of fecal bifidobacteria measured by quantitative PCR |
| Measure | Description | Time Frame |
|---|---|---|
| Infant gut metabolome | Characterization and changes in the Infant fecal metabolome as assessed by targeted and untargeted metabolomics in infant fecal samples | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks |
| Infant gut microbiome composition |
Inclusion Criteria:
Inclusion Criteria for the pregnant person:
Inclusions Criteria for the newborn:
Born at full-term ≥37+0
Birth weight above 2500 g
APGAR score of at least 7 within the first 5 min of life.
Exclusion Criteria:
Exclusion Criteria for the pregnant person:
Exclusion Criteria for the newborn :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofie Ingdam Halkjær, MSc, PhD | Contact | +4541318174 | sofie.ingdam.halkjaer@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Munk Petersen, MD, PhD, DMSc | Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling | Recruiting | Hvidovre | 2650 | Denmark |
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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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A randomized, controlled trial of healthy term in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period
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Participant, Care Provider, Investigator, Outcomes Assessor
| Placebo |
| Dietary Supplement |
Given daily from enrollement to 28 days of life |
|
| Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks |
| Infant fecal short chain fatty acids (SCFA) | Changes in SCFA production as measured by targeted metabolomics | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks |
Changes in gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples |
| Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks |
| Infant blood metabolome | Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots | 4 weeks |
| Infant bowel habits frequency | Changes in bowel habits as measured by daily stool frequency. | Daily (0-6 weeks of age) |
| Infant bowel habits stool consistency | Changes in bowel habits as measured by stool consistency. The consistency will be assessed by a modified diapered infant stool scale. | Daily from 0-6 weeks of age |
| Infant growth, weight | Infant weight in kilograms will be aggregated to determine infant growth status. | Birth, 4 weeks, 6 weeks of age. |
| Infant crying and fussing | Measured as frequency and duration (hours/minutes per day) of crying and fussing | Daily (0-6 weeks of age) |
| Pregnant person fecal microbiota composition | Gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples | 36+0-38+0 GA weeks |
| Pregnant person blood metabolome | Characterization of the pregnant person blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots | 36+0-38+0 GA weeks |
| Infant growth, length | Infant length in centimeters will be aggregated to determine infant growth status. | Birth, 4 weeks, 6 weeks of age. |
| Infant growth, head circumference | Infant head circumference in centimeters will be aggregated to determine infant growth status. | Birth, 4 weeks, 6 weeks of age. |
| D019602 |
| Food and Beverages |