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Completed

NCT Number: NCT04685252

Investigating a Probiotic on Mothers' Mood and Stress

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.

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Key information

Conditions

Perinatal Problems Mood Change Stress-related Problem

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Singapore Institute for Clinical Sciences, A*STAR Research Entities

Singapore, 117609

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(BL) NCC3001

Other

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

Other names: Bifidobacterium longum (BL) NCC3001

Placebo

Other

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

Other names: Maltodextrin

Primary outcomes

  1. Change in EPDS score

    Time frame: through study completion, an average of 6 months

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

  2. Change in STAI score

    Time frame: through study completion, an average of 6 months

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

Secondary outcomes

  1. 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

  2. Salivary Cortisol

    Time frame: through study completion, an average of 6 months

    Measure change in the salivary cortisol levels

  3. Parenting stress

    Time frame: 12 weeks post-partum

    Measured by the Parenting Stress Index (PSI) questionnaire

  4. Sleep quality

    Time frame: 36 weeks pre-partum and 12 weeks post-partum

    Measured by the Pittsburgh sleep quality index (PSQI)

  5. Microbiota composition of stool

    Time frame: Baseline to 12 weeks post-partum

    Measure changes in the microbiota composition and probiotic strain colonization

  6. Gastrointestinal comfort

    Time frame: through study completion, an average of 6 months

    Measure changes in Gastrointestinal symptom rating score (GSRS)

  7. Breastfeeding practices

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

    Measure changes in Early Feeding Questionnaire (EFQ)

  8. Anxiety and depressive symptoms

    Time frame: Baseline and at 12 weeks post-partum

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

  9. Digital assessments of stress

    Time frame: Throughout the entire study

    Change in stress index measured using ANURA application

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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