The primary objective is to assess feasibility of a food supplement (multispecies probiotic) placebo-controlled, randomised controlled, double blind intervention in pregnant women in their late second/third trimester of pregnancy, to reduce symptoms…
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
- Mood disorders and disturbances NEC
Synonym
Health condition
angstklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background 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 can
reduce levels of depression or anxiety. Probiotics ingested by the mother may
offer a promising, relatively cheap and accessible intervention to complement
current existing effective treatments to reduce symptoms of anxiety or
depression during pregnancy. Therefore, this pilot study evaluates the
feasibility of a multispecies probiotic intervention in pregnant women, as an
adjuvant therapy, to reduce prenatal depression and anxiety, ultimately to
improve maternal and infant health.
Study objective
The primary objective is to assess feasibility of a food supplement
(multispecies probiotic) placebo-controlled, randomised controlled, double
blind intervention in pregnant women in their late second/third trimester of
pregnancy, to reduce symptoms of depression and anxiety, in preparation for a
larger randomized controlled trial (RCT). Additionally, the potential
effectiveness of probiotics will also be recorded.
Study design
Feasibility assessment of a double-blind, placebo-controlled, randomised
controlled pilot trial in the prenatal care setting in the Netherlands. One
group (intervention group) orally consume food supplement (multispecies
probiotic mixture) and effectiveness will be compared with one group orally
consuming placebo (placebo group). A concealed computer generated list is used
to randomise participants, with an allocation of 1:1 to the intervention and
placebo.
Intervention
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 in case of preterm labour.
Study burden and risks
There is ample evidence that symptoms of anxiety and depression during late
pregnancy are risk factors for adverse child health outcomes. The probiotic
supplement used in this study is available for consumers on the international
market and all bacterial strains have a QPS-status. The latter indicates that
the experts of the European Food Safety Authority (EFSA) deems them safe for
consumption. Most importantly for this study, to date, probiotic intake has not
been associated with severe adverse health effects in the mother, fetus, infant
or child and intake of probiotics by healthy (pregnant) subjects is therefore
considered safe (Dugoua et al, 2009a ;. Huurre, Laitinen, Rautava , Korkeamäki
& Isolauri, 2008; R Luoto, Kalliomäki, Laitinen, & Isolauri, 2010; Snydman,
2008; VandeVusse, Safdar & Hanson, 2013, Rutten et al., 2015).
1) Intervention group:
Disadvantage: Participants will undertake an extra visit to their echo center
(Fara, Ede) or to the DPBLab (Radboud, Nijmegen). They will consume a probiotic
drink once a day for 8-14 weeks (depending on the time of birth). Participants
collect stool samples at home four times (two maternal and two baby stool
collections) and complete questionnaires. Further, two vaginal microbiota
samples and one hair sample is collected. The disadvantage here is the time
invested in the study and routine intake of probiotics. Previous studies with
probiotics in pregnant women did not cause serious side effects, women may
possibly suffer from bloating, cramps and/or altered bowel habits. The women in
the intervention group continue with their standard medical or psychological
treatment, and therefore we expect no additional psychological risks.
Advantage: possible reduction in feelings of anxiety and depression, possible
improvement of intestinal and vaginal microbiota.
2) Placebo group:
Participants will undertake an extra visit to their echo center (Fara, Ede) or
to the DPBLab (Radboud, Nijmegen). They will consume a probiotic drink once a
day for 8-14 weeks (depending on the time of birth). Participants collect stool
samples at home four times (two maternal and two baby stool collections) and
complete questionnaires. Further, two vaginal microbiota samples and one hair
sample is collected. The disadvantage here is the time invested in the study
and routine intake of probiotics. The time invested in the study is similar to
the intervention group. The women in the control group continue with their
standard medical or psychological treatment, and therefore we expect no
additional risk in the control group.
Montessorilaan 3
Nijmegen 6525 HP
NL
Montessorilaan 3
Nijmegen 6525 HP
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL57780.091.16 |
| OMON | NL-OMON26403 |