Investigating a Probiotic on Mothers' Mood and Stress (Promote)

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.

Study Overview

• Status: Completed
• Conditions: Mood Change; Perinatal Problems; Stress-related Problem
• Intervention / Treatment: Other: (BL) NCC3001; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117609
    • Singapore Institute for Clinical Sciences, A*STAR Research Entities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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: Bifidobacterium longum (BL) NCC3001
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: Maltodextrin
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: Bifidobacterium longum (BL) NCC3001; Other: Placebo; Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.; Other Names: Maltodextrin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Chair: Lisa Fries, PhD., NESTLE RESEARCH

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: probiotic; stress; mood; perinatal
• Other Study ID Numbers: 19.16.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No