Promote: Investigating a Probiotic on Mothers' Mood and Stress
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pre-Partum and Post-Partum (BL) NCC3001 One stickpack containing probiotic strain (BL) NCC3001, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum. |
Other: (BL) NCC3001
Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.
Other Names:
|
| Placebo Comparator: Placebo Control One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum. |
Other: Placebo
Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.
Other Names:
|
| Experimental: Post-Partum (BL) NCC3001 (Crossover Arm) 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. |
Other: (BL) NCC3001
Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.
Other Names:
Other: Placebo
Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in EPDS score [through study completion, an average of 6 months]
Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)
- Change in STAI score [through study completion, an average of 6 months]
Measure change in trend of State Trait Anxiety Inventory (STAI)
Secondary Outcome Measures
- Risk of EPDS score ≥ 13 [through study completion, an average of 6 months]
Number of subjects reaching Edinburgh Postnatal Depression Scale (EPDS) ≥ 13
- Salivary Cortisol [through study completion, an average of 6 months]
Measure change in the salivary cortisol levels
- Parenting stress [12 weeks post-partum]
Measured by the Parenting Stress Index (PSI) questionnaire
- Sleep quality [36 weeks pre-partum and 12 weeks post-partum]
Measured by the Pittsburgh sleep quality index (PSQI)
- Microbiota composition of stool [Baseline to 12 weeks post-partum]
Measure changes in the microbiota composition and probiotic strain colonization
- Gastrointestinal comfort [through study completion, an average of 6 months]
Measure changes in Gastrointestinal symptom rating score (GSRS)
- Breastfeeding practices [Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)]
Measure changes in Early Feeding Questionnaire (EFQ)
- Anxiety and depressive symptoms [Baseline and at 12 weeks post-partum]
Measured by change in Hospital anxiety and depression scale (HADs)
- Digital assessments of stress [Throughout the entire study]
Change in stress index measured using ANURA application
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pregnant women aged 21 years-old or above at recruitment
-
Willing and able to provide written informed consent
-
Gestational age of 28-32 weeks at Randomization
-
Singleton pregnancy at Recruitment
-
Able to respond to questionnaires in English
-
Hospital Anxiety and Depressive Scale (HADS) score of ≥ 5 (out of 21) for either subscale to indicate some general feelings of low mood and/or stress at screening
-
Intention to breastfeed
Exclusion Criteria:
-
Not willing and/or not able to comply with the study procedures and requirements
-
Food allergy
-
Has taken probiotic supplements in the period of 4 weeks prior to screening
-
Has received pharmacological treatment for anxiety and/or depression in the period of 12 weeks prior to recruitment
-
Major complications during pregnancy e.g., pre-eclampsia, gestational diabetes requiring insulin intervention, severe intra-uterine growth restriction (IUGR), fetal anomalies that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
-
Pre-existing medical conditions e.g., hypertension, diabetes mellitus, thyroid diseases, autoimmune diseases such as Systemic Lupus Erythematosus, antiphospholipid syndrome and other major chronic illness that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
-
Active participation in another clinical trial or on-going observational study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Singapore Institute for Clinical Sciences, A*STAR Research Entities | Singapore | Singapore | 117609 |
Sponsors and Collaborators
- Nestlé
Investigators
- Study Chair: Lisa Fries, PhD., NESTLE RESEARCH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19.16.NRC