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

March 22, 2023 updated by: Société des Produits Nestlé (SPN)
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in EPDS score
Time Frame: through study completion, an average of 6 months
Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)
through study completion, an average of 6 months
Change in STAI score
Time Frame: through study completion, an average of 6 months
Measure change in trend of State Trait Anxiety Inventory (STAI)
through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk of EPDS score ≥ 13
Time Frame: through study completion, an average of 6 months
Number of subjects reaching Edinburgh Postnatal Depression Scale (EPDS) ≥ 13
through study completion, an average of 6 months
Salivary Cortisol
Time Frame: through study completion, an average of 6 months
Measure change in the salivary cortisol levels
through study completion, an average of 6 months
Parenting stress
Time Frame: 12 weeks post-partum
Measured by the Parenting Stress Index (PSI) questionnaire
12 weeks post-partum
Sleep quality
Time Frame: 36 weeks pre-partum and 12 weeks post-partum
Measured by the Pittsburgh sleep quality index (PSQI)
36 weeks pre-partum and 12 weeks post-partum
Microbiota composition of stool
Time Frame: Baseline to 12 weeks post-partum
Measure changes in the microbiota composition and probiotic strain colonization
Baseline to 12 weeks post-partum
Gastrointestinal comfort
Time Frame: through study completion, an average of 6 months
Measure changes in Gastrointestinal symptom rating score (GSRS)
through study completion, an average of 6 months
Breastfeeding practices
Time Frame: Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)
Measure changes in Early Feeding Questionnaire (EFQ)
Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)
Anxiety and depressive symptoms
Time Frame: Baseline and at 12 weeks post-partum
Measured by change in Hospital anxiety and depression scale (HADs)
Baseline and at 12 weeks post-partum
Digital assessments of stress
Time Frame: Throughout the entire study
Change in stress index measured using ANURA application
Throughout the entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Lisa Fries, PhD., Nestlé Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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