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Pregnancy Complications - A Probiotic Interventional Study

S

Sahlgrenska University Hospital

Status

Completed

Conditions

Preeclampsia
Preterm Birth

Treatments

Drug: placebo
Drug: probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT02693041
Dnr. 929-11

Details and patient eligibility

About

Investigators hypothesize that

a) probiotics decrease the overall inflammatory state in the pregnant woman, especially in women with high risk pregnancies.

Full description

The main of the Project is to determine if dietary supplementation intake of probiotics are associated with a decreased inflammatory response in pregnant women, especially those with a history of previous preterm birth or preeclampsia, in a randomized clinical trial. Investigators also want to further investigate the relationship between intake of probiotics and the degree of inflammation in different compartments during pregnancy to see how the probiotic components affect the inflammatory state in the women.

Enrollment

105 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

105 participants in 6 patient groups, including a placebo group

PROBIOTIC in low-risk women
Active Comparator group
Description:
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.
Treatment:
Drug: probiotic
PLACEBO in low-risk women
Placebo Comparator group
Description:
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.
Treatment:
Drug: placebo
PROBIOTIC in women with a prior PTB
Active Comparator group
Description:
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.
Treatment:
Drug: probiotic
PLACEBO in women with a prior PTB
Placebo Comparator group
Description:
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.
Treatment:
Drug: placebo
PROBIOTIC in women with a prior PE
Active Comparator group
Description:
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.
Treatment:
Drug: probiotic
PLACEBO in women with a prior PE
Placebo Comparator group
Description:
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.
Treatment:
Drug: placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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