angstklachten anxiety Depression
Conditions
Interventions
Women orally consume multispecies probiotic mixture (2,5 x 109 CFU/g)
once-daily versus placebo from 26 weeks gestation until delivery (8-14 weeks).
This ensures at least 8 weeks of probiotic intake
Sponsors
Radboud Universiteit Nijmegen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the number of successfully met feasibility criteria linked to the intervention and the study design. For a full RCT two groups of 75 women (N = 150 total) need to be included to reach a significant difference between two groups (placebo vs. probiotics) regarding reduction of depression symptoms (a priori analysis; with 0:05 significance level, power of 80%, effect size f = 0.187, 25% drop out). The aim of the present pilot study is to investigate the feasibility of a complete study. Therefore, ~ 27% of a full study, 20 women per arm (N = 40 total) will be included. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are questionnaire data and (microbial) sample data collected during the perinatal period assessing physical and mental health in mothers and their children. Questionnaire data pre and post intervention are collected with the Edinburgh Depression Scale (EDS), Leiden Index of Depression Sensitivity, Revised (LEIDS-R), Pregnancy Related Anxiety Questionnaire-Revised (PRAQ-R), State-trait Anxiety Inventory (STAI-S), Pregnancy-related daily hassles (PES), Algemene Problemen Lijst (APL), Maternal Antenatal Attachment Scale (MAAS) and Maternal Postnatal Attachment Scale (MPAS). Sleep is measured with the Pittsburgh Sleep Quality Index (PSQI). Biological parameters include maternal hair cortisol, maternal vaginal and intestinal microbial composition, and infant intestinal microbial composition. | — |
Countries
Netherlands
Outcome results
None listed