An interventional study of Probiotic and Placebo in Healthy Infants, sponsored by Hvidovre University Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 0 Days to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Other
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.
Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
"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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probiotic Dietary supplement
Other: Probiotic
Identical looking placebo consisting of maltodextrin
Dietary Supplement: Placebo
Given daily from 14 days of age until 9 months of age
Given daily from 14 days of age until 9 months of age
Total abundance of Bifidobacteria
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
Time frame: At 3 months of age
Infant fecal pH
Changes in Fecal pH measured in fecal water from fecal samples
Time frame: 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
Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)
Time frame: 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
Time frame: 4 months, 5 months, 6 months
Infant gut metabolome composition
Changes in the overall infant fecal metabolome assessed by untargeted metabolomics
Time frame: 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
Quantification of metabolites in infant fecal samples measured by targeted metabolomics
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 3-4 weeks of age, 2-3 months and 8-10 months of age
Plan to share: No
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