Pregnancy Complications - A Probiotic Interventional Study

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT02693041

Collaborator

(none)

105

Enrollment

Location

Arms

111.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators hypothesize that

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

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Preterm Birth	Drug: probiotic Drug: placebo	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Pregnancy Complications - A Probiotic Interventional Study

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Sep 27, 2021

Actual Study Completion Date :

Sep 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PROBIOTIC in low-risk women 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.	Drug: probiotic 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. Other Names: Lactobacillus rhamnosus LGG
Placebo Comparator: PLACEBO in low-risk women 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.	Drug: placebo 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.
Active Comparator: PROBIOTIC in women with a prior PTB 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.	Drug: probiotic 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. Other Names: Lactobacillus rhamnosus LGG
Placebo Comparator: PLACEBO in women with a prior PTB 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.	Drug: placebo 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.
Active Comparator: PROBIOTIC in women with a prior PE 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.	Drug: probiotic 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. Other Names: Lactobacillus rhamnosus LGG
Placebo Comparator: PLACEBO in women with a prior PE 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.	Drug: placebo 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.

Outcome Measures

Primary Outcome Measures

Inflammatory modulation of Lactobacillus Rhamnosus in low risk mothers. [at recruitment, week 25, week 35 of gestation]
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.
Inflammatory modulation of Lactobacillus Rhamnosus in mothers with previous preterm birth. [at recruitment, week 25, week 35 of gestation]
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.
Inflammatory modulation of Lactobacillus Rhamnosus in mothers with previous preeclampsia. [at recruitment, week 25, week 35 of gestation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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