Clinical trial NCT04685252: Investigating a Probiotic on Mothers' Mood and Stress
Official title: Investigating a Probiotic on Mothers' Mood and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Problems
Mood Change
Stress-related Problem
Keywords: probiotic
mood
stress
perinatal
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 184
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in EPDS score
timeFrame: through study completion, an average of 6 months
measure: Change in STAI score
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Risk of EPDS score ≥ 13
timeFrame: through study completion, an average of 6 months
measure: Salivary Cortisol
timeFrame: through study completion, an average of 6 months
measure: Parenting stress
timeFrame: 12 weeks post-partum
measure: Sleep quality
timeFrame: 36 weeks pre-partum and 12 weeks post-partum
measure: Microbiota composition of stool
timeFrame: Baseline to 12 weeks post-partum
measure: Gastrointestinal comfort
timeFrame: through study completion, an average of 6 months
measure: Breastfeeding practices
timeFrame: Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks)
measure: Anxiety and depressive symptoms
timeFrame: Baseline and at 12 weeks post-partum
measure: Digital assessments of stress
timeFrame: Throughout the entire study
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute for Clinical Sciences, A*STAR Research Entities
Study officials:
affiliation: NESTLE RESEARCH
name: Lisa Fries, PhD.
role: STUDY_CHAIR
References: