Investigating a Probiotic on Mothers' Mood and Stress

Not Applicable

Completed

• Conditions: Mood Change; Perinatal Problems; Stress-related Problem

• Registration Number: NCT04685252
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

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 Timeline

• Study Start: 2020-11-06
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Primary Completion: 2022-02-24
• Study Completion: 2022-05-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in STAI score	through study completion, an average of 6 months	Measure change in trend of State Trait Anxiety Inventory (STAI)
Change in EPDS score	through study completion, an average of 6 months	Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)

Secondary Outcome Measures

Name	Time	Method
Sleep quality	36 weeks pre-partum and 12 weeks post-partum	Measured by the Pittsburgh sleep quality index (PSQI)
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
Microbiota composition of stool	Baseline to 12 weeks post-partum	Measure changes in the microbiota composition and probiotic strain colonization
Digital assessments of stress	Throughout the entire study	Change in stress index measured using ANURA application
Anxiety and depressive symptoms	Baseline and at 12 weeks post-partum	Measured by change in Hospital anxiety and depression scale (HADs)
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)
Parenting stress	12 weeks post-partum	Measured by the Parenting Stress Index (PSI) questionnaire

Trial Locations

Locations (1)

Singapore Institute for Clinical Sciences, A*STAR Research Entities; 🇸🇬 Singapore, Singapore