Pregnancy Complications - A Probiotic Interventional Study

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