A randomized, double-blind, placebo-controlled, pilot trial of probiotics in pregnant women with symptoms of anxiety and depression. - PIP (Probiotics In Pregnancy)

Radboud Universiteit Nijmegen0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•1. Healthy pregnant women in obstetric care in the Netherlands with at least elevated symptoms of depression and/or anxiety (resp. EDS * 10; STAI-S > 40)
•2. Women who can start daily probiotic intake from *26 weeks gestational age until delivery (Note: the upper limit of *26 weeks allows time to complete at least 8 weeks of probiotic intake prior to delivery) (Gestation is based on last menstrual period and early ultrasound).

•1) Multiple pregnancy (increased obstetric risk);
•2) High suicidal risk according to suicidality subscale score on the MINI International Neuropsychiatric Interview;
•3) Illegal drug use;
•4) Having a psychiatric history on psychoses and bipolar disorder;
•5) Medically diagnosed with inflammatory bowel disease;
•6) History of major gastro-intestinal surgery (e.g. colectomy);
•7) Hypersensitivity or allergy to any ingredients in the probiotic product;
•8) History of using oral multi-species probiotic EcologicBarrier;
•9) Presently using food containing probiotics (Actimel etc.) and not willing to stop these at least 2 weeks prior to the start of the study;
•10) No mastery of the Dutch language.

发起方