|- candidate number||26781|
|- NTR Number||NTR6219|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-feb-2017|
|- Secondary IDs||NL57780.091.16 |
|- Public Title||Probiotics in Pregnancy pilot study|
|- Scientific Title||Probiotics in Pregnancy pilot study|
|- ACRONYM||PIP pilot study|
|- hypothesis||This randomized controlled pilot study evaluates the feasibility of probiotic food supplement intervention in pregnant women, as an adjuvant therapy, to reduce prenatal maternal depression and anxiety. |
Our first hypothesis is that all feasibility criteria linked to the intervention and study design will be met (e.g feasibility of recruitment pathways, participant retention, acceptability of study measures).
Our second hypothesis is that probiotic consumption will lead to a reduction of levels of prenatal maternal anxiety, depression and stress.
|- Healt Condition(s) or Problem(s) studied||Anxiety, Depression, Pregnancy, Probiotics|
|- Inclusion criteria||1. Healthy pregnant women (>18 years) 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 (Gestation is based on last menstrual period and early ultrasound)
|- 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 the interventional product;
9) Presently using food containing probiotics (Actimel etc.) and not willing to stop these at least 2 weeks prior to the start of the interventional product intake;
10) No mastery of the Dutch language;
11) Generalized autoimmune disorder (e.g. artritis, SLE, ulcerative colitis, Crohn’s disease, Bechterew’s disease etc.) and/or treatment with immunosuppressive therapy (e.g. radiation, chemotherapy).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-mrt-2017|
|- planned closingdate||7-sep-2018|
|- Target number of participants||40|
|- Interventions||Subjects will be randomly allocated to either control group (placebo) or intervention probiotic group. Probiotic/placebo intake once daily for 8 up to 14 constituent weeks.|
|- Primary outcome||The primary outcome is the number of successfully met
feasibility criteria linked to the intervention and study design.|
• feasibility of recruitment pathways (the ACCEPT checklist);
• participant retention;
• acceptability of study measures;
• number of women in Wageningen region (the Netherlands) eligible for this pilot trial.
|- Secondary outcome||Secondary outcomes include:|
• Quantitative data assessing mental health in mothers (anxiety, stress and depression);
• Crying behaviour in children;
• Biological data, including maternal cortisol, maternal vaginal microbiota, maternal intestinal microbiota
and intestinal microbial composition, and infant intestinal
|- Timepoints||Baseline/T0: week 26 gestation|
T1: week 34 gestation
T2: day 7 post partum
T3: week 4 post partum
|- Trial web site||NA|
|- CONTACT FOR PUBLIC QUERIES||drs.
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Carolina de Weerth|
|- Sponsor/Initiator ||Behavioural Science Institute, Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Nijmegen, Winclove Bio Industries B.V., Clinical Research Rotterdam (CR2O)|
|- Brief summary||Maternal prenatal depression or anxiety during late pregnancy are risk factors for adverse health and behaviour outcomes in offspring.|
With prevalence rates of prenatal depression or anxiety ranging between 10-20%, attempts to identify feasible and effective interventions to reduce symptoms are priority in the prenatal care and clinical setting.
There are indications that probiotics, as a food supplement, by improving the intestinal microbiota, can improve mental wellbeing.
The probiotic mixture used in this study has been shown
to significantly reduce negative thoughts associated with sad mood in healthy adults.
Probiotics, with their anti-inflammatory and neuroregulatory properties, may improve intestinal microbiota in pregnant mothers and consequently their mood. Additionally, prenatal ingestion of probiotics by mothers may improve their vaginal microbiota, which may in turn positively influence their offspring’s developing microbiota.
This study assesses the feasibility of a multispecies
probiotic intervention in pregnant women, to reduce symptoms of depression and anxiety, in preparation for a larger randomised controlled trial (RCT).
|- Main changes (audit trail)|
|- RECORD||28-feb-2017 - 22-mrt-2017|