Investigating a Probiotic on Mothers' Mood and Stress

NCT04685252 | Completed DMC

• 1 other identifier: 19.16.NRC
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Problems; Mood Change; Stress-related Problem

Keywords

probiotic; mood; stress; perinatal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Risk of EPDS score ≥ 13

  through study completion, an average of 6 months

• Salivary Cortisol

  through study completion, an average of 6 months

• Parenting stress

  12 weeks post-partum

• Sleep quality

  36 weeks pre-partum and 12 weeks post-partum

• Microbiota composition of stool

  Baseline to 12 weeks post-partum

Study Arms (3)

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.

Other: (BL) NCC3001

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.

Other: Placebo

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.

Other: (BL) NCC3001; Other: Placebo

Interventions

(BL) NCC3001 OTHER

Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.

Also known as: Bifidobacterium longum (BL) NCC3001

Post-Partum (BL) NCC3001 (Crossover Arm); Pre-Partum and Post-Partum (BL) NCC3001

Placebo OTHER

Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.

Also known as: Maltodextrin

Placebo Control; Post-Partum (BL) NCC3001 (Crossover Arm)

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Singapore Institute for Clinical Sciences, A*STAR Research Entities

Singapore, 117609, Singapore

Location

Related Publications (1)

• 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.

  PMID: 37018024 DERIVED

MeSH Terms

Interventions

maltodextrin

Study Officials

• Lisa Fries, PhD.

  NESTLE RESEARCH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Individually unique coding for each stickpack
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 28, 2020
• Study Start: November 6, 2020
• Primary Completion: February 24, 2022
• Study Completion: May 20, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)