Investigating a Probiotic on Mothers' Mood and Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating a Probiotic on Mothers' Mood and Stress

Conditions
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Mood Change, Perinatal Problems, Stress-related Problem

Intervention / Treatment
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* Other: (BL) NCC3001
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-Partum and Post-Partum (BL) NCC3001<br>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<br>* Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.<br>* Other names: Bifidobacterium longum (BL) NCC3001;|
| Placebo Comparator: Placebo Control<br>One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum. | Other: Placebo<br>* Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.<br>* Other names: Maltodextrin;|
| Experimental: Post-Partum (BL) NCC3001 (Crossover Arm)<br>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<br>* Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.<br>* Other names: Bifidobacterium longum (BL) NCC3001;Other: Placebo<br>* Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.<br>* Other names: Maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mood, probiotic, stress, perinatal