A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of a Probiotic Dietary Supplement on the Gut Microbiome, Oxytocin Levels, Socio-emotional Functioning, and Well-being in Mother-Infant Dyads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group
研究概览
简要总结
Researchers at Massachusetts General Hospital are interested in learning more about the neurobiology of well-being in new mothers and novel ways to support them during their transition to parenthood. This study aims to evaluate well-being in new mothers and their infant and the impact of a probiotic dietary supplement on the gut microbiome. This study hopes to help improve the existing knowledge of maternal postnatal health.
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
Randomization will be performed by the unblinded study pharmacist. All study staff will be blinded to treatment assignment. The infant will be assigned to the same group as their mother.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Has active substance abuse in the past 6 months or a history of opioid use disorder
- •Has diabetes mellitus except for diet controlled gestational diabetes
- •Has uncontrolled thyroid disease
- •Has inflammatory gastrointestinal disease
- •Has active suicidal ideation
- •Has a history of psychosis
- •Has a history of an autism spectrum disorder
- •Plans to take other probiotics (other than study product) during study participation
- •Plans to take systemic hormonal contraception during study participation (Note: intra-uterine device is allowed)
- •Is receiving any systemically administered immunosuppressant medication on a chronic basis
- •Has a clinically significant or uncontrolled concomitant illness or condition that would put the subject at risk or jeopardize the objectives of the study
- •Has a contraindication, sensitivity, or known allergy to any ingredient of the study product
- •Is considered, in the opinion of the Principal Investigator (PI), to likely be a poor attendee or unlikely for any reason to be able to comply with the study procedures
结局指标
主要结局
Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group
时间窗: 6 week
Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).
次要结局
- Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group(Baseline to Week 6)
- Change in Toronto Alexithymia Scale (TAS-20) Total Score (range: 20-100; direction: lower scores indicate better socioemotional functioning) in the probiotic versus placebo group(Baseline to Week 6)
研究者
Elizabeth Austen Lawson
Elizabeth A. Lawson, M.D., M.M.Sc.
Massachusetts General Hospital