NCT02693041 - Pregnancy Complications - A Probiotic Interventional Study | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

105

Conditions

Preeclampsia Preterm Birth

Interventions

probioticDRUG

Low-risk women, women with prior preeclampsia and women with a prior preterm birth will be randomized to be treated with LGG during pregnancy. Effect on maternal and perinatal outcome as well as the effect of treatment on immunological and inflammatory biomarkers will be evaluated.

placeboDRUG

Low-risk women, women with prior preeclampsia and women with a prior preterm birth will be randomized to be treated with placebo during pregnancy. Effect on maternal and perinatal outcome as well as the effect of treatment on immunological and inflammatory biomarkers will be evaluated.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bo Jacobsson

Gothenburg, Sweden

Outcomes

Primary Outcomes

Inflammatory modulation of Lactobacillus Rhamnosus in low risk mothers.

Intake of LGG Rhamnosus throughout the pregnancy and its effect on levels of subpopulations of lymphocytes in peripheral blood (T/B/NK-celler), and cytokine production (TNF alfa, IL10, IL12) after stimulation with E. Coli, L. paracasei and P. aerugnousa, measuring change from baseline to 25 and 35 weeks gestation.

Time frame: at recruitment, week 25, week 35 of gestation

Inflammatory modulation of Lactobacillus Rhamnosus in mothers with previous preterm birth.

Intake of LGG Rhamnosus throughout the pregnancy and its effect on levels of subpopulations of lymphocytes in peripheral blood (T/B/NK-celler), and cytokine production (TNF alfa, IL10, IL12) after stimulation with E. Coli, L. paracasei and P. aerugnousa, measuring change from baseline to 25 and 35 weeks gestation.

Time frame: at recruitment, week 25, week 35 of gestation

Inflammatory modulation of Lactobacillus Rhamnosus in mothers with previous preeclampsia.

Intake of LGG Rhamnosus throughout the pregnancy and its effect on levels of subpopulations of lymphocytes in peripheral blood (T/B/NK-celler), and cytokine production (TNF alfa, IL10, IL12) after stimulation with E. Coli, L. paracasei and P. aerugnousa, measuring change from baseline to 25 and 35 weeks gestation.

Time frame: at recruitment, week 25, week 35 of gestation