Investigating a Probiotic on Mothers' Mood and Stress

Nestlé

Status: Completed

Conditions: Perinatal Problems; Mood Change; Stress-related Problem

Treatments: Other: Placebo; Other: (BL) NCC3001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04685252

19.16.NRC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 3 patient groups, including a placebo group

Pre-Partum and Post-Partum (BL) NCC3001

Experimental group

Description:

One stickpack containing probiotic strain (BL) NCC3001, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum.

Treatment:

Other: (BL) NCC3001

Placebo Control

Placebo Comparator group

Description:

One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily over a period of 6 months; 3 months pre- and post-partum.

Treatment:

Other: Placebo

Post-Partum (BL) NCC3001 (Crossover Arm)

Experimental group

Description:

One Placebo stickpack containing maltodextrin, dissolved and consumed oral daily for 3 months during pre-partum, followed with switch to one stickpack containing probiotic strain (BL) NCC3001, dissolved and consumed oral daily for 3 months post-partum.

Treatment:

Other: (BL) NCC3001

Other: Placebo