This is a randomized, placebo-controlled, double-blind, 3 parallel-arm study in pregnant women aged 21 years old and above. The study aims to assess changes in perinatal mood and stress when administering a probiotic starting from either the 3rd trimester (i.e 28-32 weeks of gestational age) or immediately after birth, until 12 weeks post-partum.
To date, limited evidence is available for nutritional interventions in the role of modulation of perinatal mood and stress, even less so for probiotics. The probiotic strain Bifidobacterium longum (BL) NCC3001 has previously been shown to normalize anxiety-like behavior in preclinical models and to reduce feelings of low mood and emotional reaction to fearful stimulus in human adults with irritable bowel syndrome (IBS). The strain is also considered safe and has previously been administered to pregnant and lactating women as well as infants. Therefore, the study aims to evaluate the effect of probiotic (BL) NCC3001 on mood and stress levels during the perinatal period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
184
Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.
Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.
Singapore Institute for Clinical Sciences, A*STAR Research Entities
Singapore, Singapore
Change in EPDS score
Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)
Time frame: through study completion, an average of 6 months
Change in STAI score
Measure change in trend of State Trait Anxiety Inventory (STAI)
Time frame: through study completion, an average of 6 months
Risk of EPDS score ≥ 13
Number of subjects reaching Edinburgh Postnatal Depression Scale (EPDS) ≥ 13
Time frame: through study completion, an average of 6 months
Salivary Cortisol
Measure change in the salivary cortisol levels
Time frame: through study completion, an average of 6 months
Parenting stress
Measured by the Parenting Stress Index (PSI) questionnaire
Time frame: 12 weeks post-partum
Sleep quality
Measured by the Pittsburgh sleep quality index (PSQI)
Time frame: 36 weeks pre-partum and 12 weeks post-partum
Microbiota composition of stool
Measure changes in the microbiota composition and probiotic strain colonization
Time frame: Baseline to 12 weeks post-partum
Gastrointestinal comfort
Measure changes in Gastrointestinal symptom rating score (GSRS)
Time frame: through study completion, an average of 6 months
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Breastfeeding practices
Measure changes in Early Feeding Questionnaire (EFQ)
Time frame: Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)
Anxiety and depressive symptoms
Measured by change in Hospital anxiety and depression scale (HADs)
Time frame: Baseline and at 12 weeks post-partum
Digital assessments of stress
Change in stress index measured using ANURA application
Time frame: Throughout the entire study