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Pregnancy Complications - A Probiotic Interventional Study

Primary Purpose

Preeclampsia, Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
probiotic
placebo
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring Probiotics, inflammation, immunological response, preterm birth, preeclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bo Jacobsson

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

PROBIOTIC in low-risk women

PLACEBO in low-risk women

PROBIOTIC in women with a prior PTB

PLACEBO in women with a prior PTB

PROBIOTIC in women with a prior PE

PLACEBO in women with a prior PE

Arm 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.

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 The capsules of the placebo Group have similar content but lack the probiotic lactic acid bacteria which has been replaced by maltodextrin to make the mg amount equal.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2015
Last Updated
June 1, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02693041
Brief Title
Pregnancy Complications - A Probiotic Interventional Study
Official Title
Pregnancy Complications - A Probiotic Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Preterm Birth
Keywords
Probiotics, inflammation, immunological response, preterm birth, preeclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROBIOTIC in low-risk women
Arm Type
Active Comparator
Arm 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.
Arm Title
PLACEBO in low-risk women
Arm Type
Placebo Comparator
Arm 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.
Arm Title
PROBIOTIC in women with a prior PTB
Arm Type
Active Comparator
Arm 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.
Arm Title
PLACEBO in women with a prior PTB
Arm Type
Placebo Comparator
Arm 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.
Arm Title
PROBIOTIC in women with a prior PE
Arm Type
Active Comparator
Arm 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.
Arm Title
PLACEBO in women with a prior PE
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
probiotic
Other Intervention Name(s)
Lactobacillus rhamnosus, LGG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inflammatory modulation of Lactobacillus Rhamnosus in low risk mothers.
Description
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
Title
Inflammatory modulation of Lactobacillus Rhamnosus in mothers with previous preterm birth.
Description
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
Title
Inflammatory modulation of Lactobacillus Rhamnosus in mothers with previous preeclampsia.
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Jacobsson, Professor
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bo Jacobsson
City
Gothenburg
ZIP/Postal Code
416 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24848255
Citation
Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599.
Results Reference
result
PubMed Identifier
22916296
Citation
Cobo T, Kacerovsky M, Palacio M, Hornychova H, Hougaard DM, Skogstrand K, Jacobsson B. Intra-amniotic inflammatory response in subgroups of women with preterm prelabor rupture of the membranes. PLoS One. 2012;7(8):e43677. doi: 10.1371/journal.pone.0043677. Epub 2012 Aug 20.
Results Reference
result
PubMed Identifier
11921380
Citation
Goncalves LF, Chaiworapongsa T, Romero R. Intrauterine infection and prematurity. Ment Retard Dev Disabil Res Rev. 2002;8(1):3-13. doi: 10.1002/mrdd.10008.
Results Reference
result
PubMed Identifier
16187156
Citation
Jimenez E, Fernandez L, Marin ML, Martin R, Odriozola JM, Nueno-Palop C, Narbad A, Olivares M, Xaus J, Rodriguez JM. Isolation of commensal bacteria from umbilical cord blood of healthy neonates born by cesarean section. Curr Microbiol. 2005 Oct;51(4):270-4. doi: 10.1007/s00284-005-0020-3. Epub 2005 Sep 20.
Results Reference
result
PubMed Identifier
18281199
Citation
Jimenez E, Marin ML, Martin R, Odriozola JM, Olivares M, Xaus J, Fernandez L, Rodriguez JM. Is meconium from healthy newborns actually sterile? Res Microbiol. 2008 Apr;159(3):187-93. doi: 10.1016/j.resmic.2007.12.007. Epub 2008 Jan 11.
Results Reference
result
PubMed Identifier
20980489
Citation
Myhre R, Brantsaeter AL, Myking S, Gjessing HK, Sengpiel V, Meltzer HM, Haugen M, Jacobsson B. Intake of probiotic food and risk of spontaneous preterm delivery. Am J Clin Nutr. 2011 Jan;93(1):151-7. doi: 10.3945/ajcn.110.004085. Epub 2010 Oct 27.
Results Reference
result
PubMed Identifier
21821542
Citation
Brantsaeter AL, Myhre R, Haugen M, Myking S, Sengpiel V, Magnus P, Jacobsson B, Meltzer HM. Intake of probiotic food and risk of preeclampsia in primiparous women: the Norwegian Mother and Child Cohort Study. Am J Epidemiol. 2011 Oct 1;174(7):807-15. doi: 10.1093/aje/kwr168. Epub 2011 Aug 5.
Results Reference
result
PubMed Identifier
24034345
Citation
Bertelsen RJ, Brantsaeter AL, Magnus MC, Haugen M, Myhre R, Jacobsson B, Longnecker MP, Meltzer HM, London SJ. Probiotic milk consumption in pregnancy and infancy and subsequent childhood allergic diseases. J Allergy Clin Immunol. 2014 Jan;133(1):165-71.e1-8. doi: 10.1016/j.jaci.2013.07.032. Epub 2013 Sep 10.
Results Reference
result
PubMed Identifier
19285652
Citation
Yeganegi M, Watson CS, Martins A, Kim SO, Reid G, Challis JR, Bocking AD. Effect of Lactobacillus rhamnosus GR-1 supernatant and fetal sex on lipopolysaccharide-induced cytokine and prostaglandin-regulating enzymes in human placental trophoblast cells: implications for treatment of bacterial vaginosis and prevention of preterm labor. Am J Obstet Gynecol. 2009 May;200(5):532.e1-8. doi: 10.1016/j.ajog.2008.12.032. Epub 2009 Mar 14.
Results Reference
result
PubMed Identifier
20811016
Citation
Yeganegi M, Leung CG, Martins A, Kim SO, Reid G, Challis JR, Bocking AD. Lactobacillus rhamnosus GR-1 stimulates colony-stimulating factor 3 (granulocyte) (CSF3) output in placental trophoblast cells in a fetal sex-dependent manner. Biol Reprod. 2011 Jan;84(1):18-25. doi: 10.1095/biolreprod.110.085167. Epub 2010 Sep 1.
Results Reference
result

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Pregnancy Complications - A Probiotic Interventional Study

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