Investigating a Probiotic on Mothers' Mood and Stress

NCT ID: NCT04685252

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2022-05-20

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.

Conditions

Perinatal Problems; Mood Change; Stress-related Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

(BL) NCC3001

Intervention Type: OTHER

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

Placebo Control

One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

(BL) NCC3001

Intervention Type: OTHER

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

Placebo

Intervention Type: OTHER

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

Interventions

(BL) NCC3001

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Bifidobacterium longum (BL) NCC3001; Maltodextrin

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Fries, PhD.

Role: STUDY_CHAIR

NESTLE RESEARCH

Locations

Singapore Institute for Clinical Sciences, A*STAR Research Entities

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 37018024 (View on PubMed)

Other Identifiers

19.16.NRC

Identifier Type: -

Identifier Source: org_study_id