NCT04685252

Investigating a Probiotic on Mothers' Mood and Stress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perinatal Problems
• Mood Change
• Stress-related Problem

Interventions

Type	Name	Description
OTHER	(BL) NCC3001	Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.
OTHER	Placebo	Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.

Timeline

• Start date: 2020-11-06
• Primary completion: 2022-02-24
• Completion: 2022-05-20
• First posted: 2020-12-28
• Last updated: 2023-03-24

Locations

1 site across 1 country: Singapore