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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Partum and Post-Partum (BL) NCC3001 | Experimental | One stickpack containing probiotic strain (BL) NCC3001, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum. |
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| Placebo Control | Placebo Comparator | One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum. |
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| Post-Partum (BL) NCC3001 (Crossover Arm) | Experimental | One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily for 3 months during pre-partum, followed with switch to one stickpack containing probiotic strain (BL) NCC3001, dissolved and consumed oral daily for 3 months post-partum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (BL) NCC3001 | Other | Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in EPDS score | Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS) | through study completion, an average of 6 months |
| Change in STAI score | Measure change in trend of State Trait Anxiety Inventory (STAI) | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of EPDS score ≥ 13 | Number of subjects reaching Edinburgh Postnatal Depression Scale (EPDS) ≥ 13 | through study completion, an average of 6 months |
| Salivary Cortisol | Measure change in the salivary cortisol levels |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Fries, PhD. | NESTLE RESEARCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Institute for Clinical Sciences, A*STAR Research Entities | Singapore | 117609 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37018024 | Derived | Toh MPS, Yang CY, Lim PC, Loh HLJ, Bergonzelli G, Lavalle L, Mardhy E, Samuel TM, Suniega-Tolentino E, Silva Zolezzi I, Fries LR, Chan SY. A Probiotic Intervention With Bifidobacterium longum NCC3001 on Perinatal Mood Outcomes (PROMOTE Study): Protocol for a Decentralized Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 5;12:e41751. doi: 10.2196/41751. |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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Individually unique coding for each stickpack
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| Placebo | Other | Matching placebo containing maltodextrin packed in stickpack, to be consumed daily. |
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| through study completion, an average of 6 months |
| Parenting stress | Measured by the Parenting Stress Index (PSI) questionnaire | 12 weeks post-partum |
| Sleep quality | Measured by the Pittsburgh sleep quality index (PSQI) | 36 weeks pre-partum and 12 weeks post-partum |
| Microbiota composition of stool | Measure changes in the microbiota composition and probiotic strain colonization | Baseline to 12 weeks post-partum |
| Gastrointestinal comfort | Measure changes in Gastrointestinal symptom rating score (GSRS) | through study completion, an average of 6 months |
| Breastfeeding practices | Measure changes in Early Feeding Questionnaire (EFQ) | 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) | Baseline and at 12 weeks post-partum |
| Digital assessments of stress | Change in stress index measured using ANURA application | Throughout the entire study |