Investigating a Probiotic on Mothers' Mood and Stress

Mood Change Clinical Trial

Official title:

Investigating a Probiotic on Mothers' Mood and Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685252
• Other study ID #: 19.16.NRC
• Status: Completed
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: May 20, 2022

Study information

• Verified date: March 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 birth, until 12 weeks post-partum.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 20, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mood Change
• Perinatal Problems
• Stress-related Problem

Intervention

Other:
• (BL) NCC3001
Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.
• Placebo
Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.

Locations

Country	Name	City	State
Singapore	Singapore Institute for Clinical Sciences, A*STAR Research Entities	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in EPDS score	Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)	through study completion, an average of 6 months
Primary	Change in STAI score	Measure change in trend of State Trait Anxiety Inventory (STAI)	through study completion, an average of 6 months
Secondary	Risk of EPDS score = 13	Number of subjects reaching Edinburgh Postnatal Depression Scale (EPDS) = 13	through study completion, an average of 6 months
Secondary	Salivary Cortisol	Measure change in the salivary cortisol levels	through study completion, an average of 6 months
Secondary	Parenting stress	Measured by the Parenting Stress Index (PSI) questionnaire	12 weeks post-partum
Secondary	Sleep quality	Measured by the Pittsburgh sleep quality index (PSQI)	36 weeks pre-partum and 12 weeks post-partum
Secondary	Microbiota composition of stool	Measure changes in the microbiota composition and probiotic strain colonization	Baseline to 12 weeks post-partum
Secondary	Gastrointestinal comfort	Measure changes in Gastrointestinal symptom rating score (GSRS)	through study completion, an average of 6 months
Secondary	Breastfeeding practices	Measure changes in Early Feeding Questionnaire (EFQ)	Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)
Secondary	Anxiety and depressive symptoms	Measured by change in Hospital anxiety and depression scale (HADs)	Baseline and at 12 weeks post-partum
Secondary	Digital assessments of stress	Change in stress index measured using ANURA application	Throughout the entire study