Pregnancy Complications - A Probiotic Interventional Study
Preeclampsia, Preterm Birth
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About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring Probiotics, inflammation, immunological response, preterm birth, preeclampsia
Eligibility Criteria
Inclusion Criteria:
- Maternal age > or = 18 y
- Singleton pregnancy
- Nulli or multiparous without maternal intercurrent diseases or pregnant women with a history of spontaneous preterm delivery or pregnant women with a history of preeclampsia.
Exclusion Criteria
- Multiple pregnancy
- Gestational age > 17+6 weeks at first visit
- Chronic intermittent diseases (e.g. diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis, Chron disease, ulcerative colitis)
- Uterus malformations
- Immunomodulatory medication
- Hormonal treatment (e.g. crinone, progesterone)
- Subject disagrees to stop intake of other products containing probiotics during study time.
- Subject is unable to provide written informed consent
Sites / Locations
- Bo Jacobsson
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
PROBIOTIC in low-risk women
PLACEBO in low-risk women
PROBIOTIC in women with a prior PTB
PLACEBO in women with a prior PTB
PROBIOTIC in women with a prior PE
PLACEBO in women with a prior PE
In low-risk women, probiotic group will be treated with the Active ingredient containing Lactobacillus rhamnosus (LGG) (> 10x8 CFU) during all pregnancy until delivery. Capsules contain maltodextrin, LGG and vegetal magnesium stearate.
In low-risk women, placebo group will be treated with the placebo ingredient during all pregnancy until delivery. The capsules of the placebo Group have similar content but lack the probiotic lactic acid bacteria which has been replaced by maltodextrin to make the mg amount equal.
In women with a prior preterm birth (PTB), probiotic Group will be treated with the Active ingredient containing Lactobacillus rhamnosus (LGG) (> 10x8 CFU) during all pregnancy until delivery. Capsules contain maltodextrin, LGG and vegetal magnesium stearate.
In women with a prior preterm birth (PTB), placebo group will be treated with the placebo ingredient during all pregnancy until delivery. The capsules of the placebo Group have similar content but lack the probiotic lactic acid bacteria which has been replaced by maltodextrin to make the mg amount equal.
In women with a prior preeclampsia (PE), probiotic Group will be treated with the Active ingredient containing Lactobacillus rhamnosus (LGG) (> 10x8 CFU) during all pregnancy until delivery. Capsules contain maltodextrin, LGG and vegetal magnesium stearate.
In women with a prior preeclampsia (PE), placebo Group will be treated with the placebo ingredient during all pregnancy until delivery. The capsules of the placebo Group have similar content but lack the probiotic lactic acid bacteria which has been replaced by maltodextrin to make the mg amount equal.