Investigating a Probiotic on Mothers' Mood and Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Change in STAI score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Individually unique coding for each stickpack
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in STAI score
时间窗: through study completion, an average of 6 months
Measure change in trend of State Trait Anxiety Inventory (STAI)
Change in EPDS score
时间窗: through study completion, an average of 6 months
Measure change in trend of Edinburgh Postnatal Depression Scale (EPDS)
次要结局
- Risk of EPDS score ≥ 13(through study completion, an average of 6 months)
- Sleep quality(36 weeks pre-partum and 12 weeks post-partum)
- Parenting stress(12 weeks post-partum)
- Salivary Cortisol(through study completion, an average of 6 months)
- Microbiota composition of stool(Baseline to 12 weeks post-partum)
- Digital assessments of stress(Throughout the entire study)
- Anxiety and depressive symptoms(Baseline and at 12 weeks post-partum)
- Gastrointestinal comfort(through study completion, an average of 6 months)
- Breastfeeding practices(Baseline and post-partum (9 days, 4 weeks, 8 weeks and 12 weeks))