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| ID | Type | Description | Link |
|---|---|---|---|
| H-25028285 | Other Identifier | Ethics Committee Case number |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Chr Hansen | INDUSTRY |
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The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
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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 14 days of age until 9 months of age |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total abundance of Bifidobacteria | Abundance of Bifidobacteria in infant fecal samples by quantitative PCR | At 3 months of age |
| 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, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year |
| Infant gut microbiome composition |
| Measure | Description | Time Frame |
|---|---|---|
| Infant gut metabolome composition | Changes in the overall infant fecal metabolome assessed by untargeted metabolomics | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year |
| Quantity of metabolites in infant fecal samples |
"Inclusion Criteria"
Inclusion Criteria for the pregnant person
Inclusions Criteria for the newborn
"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 | +45 38 62 38 62 | 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 |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Recruiting | Hvidovre | Region Sjælland | 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 in term newborns with an 8½ months intervention period from 14 days of age until 9 months of age followed by a 3 months short-term follow-up period until 1 year of age and a long-term follow-up until 18 years of age
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Participant, Care Provider, Investigator, Outcomes Assessor
| Placebo |
| Dietary Supplement |
Given daily from 14 days of age until 9 months of age |
|
Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)
| Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year |
| Proportion of infants with hard or very hard stool consistency | The proportion of infants with episodes 'hard' and/or 'very hard' stool consistency assessed as the difference in numbers of infants who experience 'hard' and /or 'very hard' stool consistency during weaning (from first introduction of solid food) between the two groups | 4 months, 5 months, 6 months |
Quantification of metabolites in infant fecal samples measured by targeted metabolomics |
| Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year |
| Infant Whole Gut Transit Time | Whole gut transit time measured by sweet corn test | 9 months and 1 year |
| Abundance of clinically relevant pathogens in feces | Abundance of clinically relevant pathogens in feces (e.g., but not limited to Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Pseudomonas aeruginosa, Enterobacter, Klebsiella, Proteus, group B Streptococcus, Clostridioides difficile, Bacillus subtilis and Acinetobacter measured by DNA/RNA sequencing of fecal samples | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year |
| Infant bowel habits | Changes in bowel habits as measured by stool frequency and stool consistency. The consistency will be assessed by a modified Diapered Infant Stool Scale continuously in an electronic diary weekly from birth to 1 year of age | Weekly (0-52 weeks of age) |
| Pediatric Quality of Life Inventory™ 2.0 Family Impact Module (PedsQL™) | Familys health-related quality of life will be measured by Pediatric Quality of Life Inventory™ 2.0 Family Impact Module (PedsQL™) The 36-item PedsQL consists of 6 scales measuring parent self-reported functioning: 1) Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and 2 scales measuring parent-reported family functioning; 7) Daily Activities (3 items) and 8) Family Relationships (5 items). A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) and higher scores indicate better functioning (less negative impact). | 3 months, 6 months, 9 months, and 1 year |
| Infant blood metabolome | Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots | 3 months, 6 months, 9 months, and 1 year |
| Alarm Distress Baby scale | Infant socioemotional development (stress and failure to thrive) will be measured by the Alarm Distress Baby scale. The scale focuses on eight distinctive areas of infant behaviour: facial expression, eye contact, general level of activity, self-stimulation gestures, vocalisations, briskness of response to stimulation, ability to initiate and maintain a relationship and ability to generate and sustain attention. It is used for infants aged 0-24 months and each item is rated from 0 to 4 with the overall score reflecting an interpretation of the baby's behaviour in a given situation. A score of 5 or above is indicative of relational withdrawal. A low score means a better outcome. | 3-4 weeks of age, 2-3 months and 8-10 months of age |
| Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling | Not yet recruiting | Hvidovre | 2650 | Denmark |
|
| D019602 |
| Food and Beverages |