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Perinatal ProblemsNCT04685252

Investigating a Probiotic on Mothers' Mood and Stress

A study testing (BL) NCC3001 in people with Perinatal Problems and Mood Change, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older, women onlyHealthy volunteers can take part
What is being tested?
(BL) NCC3001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
184 participants
Where
1 siteSingapore
Study dates
6 Nov 2020to 20 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

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

    Singapore, 117609

Other trials in Singapore

About this study

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.

Read the 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.

Being tested
(BL) NCC3001, Placebo
Keywords
probiotic, mood, stress, perinatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (BL) NCC3001Other

    Also called Bifidobacterium longum (BL) NCC3001

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

  • PlaceboOther

    Also called Maltodextrin

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

Study groups in NCT04685252
Study groupRoleWhat they receive
Pre-Partum and Post-Partum (BL) NCC3001ExperimentalOne stickpack containing probiotic strain (BL) NCC3001, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum.
Receives: Other: (BL) NCC3001
Placebo ControlPlacebo comparatorOne Placebo stickpack containing maltodextrin, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum.
Receives: Other: Placebo
Post-Partum (BL) NCC3001 (Crossover Arm)ExperimentalOne 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.
Receives: Other: (BL) NCC3001; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in EPDS score

    Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)

    Measured: through study completion, an average of 6 months

  2. Change in STAI score

    Measure change in trend of State Trait Anxiety Inventory (STAI)

    Measured: through study completion, an average of 6 months

Secondary outcomes (9)

  1. Risk of EPDS score ≥ 13

    Number of subjects reaching Edinburgh Postnatal Depression Scale (EPDS) ≥ 13

    Measured: through study completion, an average of 6 months

  2. Salivary Cortisol

    Measure change in the salivary cortisol levels

    Measured: through study completion, an average of 6 months

  3. Parenting stress

    Measured by the Parenting Stress Index (PSI) questionnaire

    Measured: 12 weeks post-partum

  4. Sleep quality

    Measured by the Pittsburgh sleep quality index (PSQI)

    Measured: 36 weeks pre-partum and 12 weeks post-partum

  5. Microbiota composition of stool

    Measure changes in the microbiota composition and probiotic strain colonization

    Measured: Baseline to 12 weeks post-partum

  6. Gastrointestinal comfort

    Measure changes in Gastrointestinal symptom rating score (GSRS)

    Measured: through study completion, an average of 6 months

  7. Breastfeeding practices

    Measure changes in Early Feeding Questionnaire (EFQ)

    Measured: Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)

  8. Anxiety and depressive symptoms

    Measured by change in Hospital anxiety and depression scale (HADs)

    Measured: Baseline and at 12 weeks post-partum

  9. Digital assessments of stress

    Change in stress index measured using ANURA application

    Measured: Throughout the entire study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start6 Nov 2020
  3. Primary completion24 Feb 2022
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685252
Sponsor's protocol ID
19.16.NRC
Status last verified
Mar 2023
First submitted
16 Dec 2020
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37018024

Questions about this trial

What is this clinical trial studying?

A study testing (BL) NCC3001 in people with Perinatal Problems and Mood Change, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EPDS score (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685252, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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