Pregnancy Complications - A Probiotic Interventional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Inflammatory modulation of Lactobacillus Rhamnosus in low risk mothers.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: probiotic (Drug)
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.
Intervention: placebo (Drug)
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.
Intervention: probiotic (Drug)
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.
Intervention: placebo (Drug)
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.
Intervention: probiotic (Drug)
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.
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Inflammatory modulation of Lactobacillus Rhamnosus in low risk mothers.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Bo Jacobsson
Clinical professor
Sahlgrenska University Hospital, Sweden