Status:
COMPLETED
Investigating a Probiotic on Mothers' Mood and Stress
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Perinatal Problems
Mood Change
Eligibility:
FEMALE
21+ years
Phase:
NA
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 administe...
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 (B...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04685252
Start Date
November 6 2020
End Date
May 20 2022
Last Update
March 24 2023
Active Locations (1)
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1
Singapore Institute for Clinical Sciences, A*STAR Research Entities
Singapore, Singapore, 117609