Pregnancy Complications - A Probiotic Interventional Study

Not Applicable

Completed

• Conditions: Preeclampsia; Preterm Birth
• Interventions: Drug: placebo; Drug: probiotic

• Registration Number: NCT02693041
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Investigators hypothesize that

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

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO in women with a prior PTB	placebo	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.
PLACEBO in low-risk women	placebo	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.
PLACEBO in women with a prior PE	placebo	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.
PROBIOTIC in low-risk women	probiotic	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.
PROBIOTIC in women with a prior PE	probiotic	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.
PROBIOTIC in women with a prior PTB	probiotic	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bo Jacobsson; 🇸🇪 Gothenburg, Sweden