Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome
NCT ID: NCT02693028
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-11-30
2018-01-31
Brief Summary
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Detailed Description
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1. How does bacteria transmit from the mother to the fetus and placenta during pregnancy and to the infant during the first 2-6 weeks after birth?
2. Does colonization of the pregnant mother and fetus/Child occur? How and when?
3. Can orally given probiotic bacteria be found in the newborn 2-6 weeks after birth, and if so where?
4. How is bacteria transported from the mother's intestinal lumen to the Child/fetus gut?
5. What impact has these bacteria on the level of inflammation in maternal and fetal compartments, especially that normally seen in the intestine of all newborns?
6. What impact has these bacteria in the bowel on a normal intestinal flora establishment?
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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probiotic lozenge
Two probiotic lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic lozenges
The women participating in the study will take two probiotic lozenges per day (morning and evening) after meals.Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic capsule
Two probiotic capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic capsules
The women participating in the study will take two probiotic capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic chewing gum
The probiotic chewing gum should be chewed on for about 10 minutes. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic chewing gum
The women participating in the study will take two probiotic chewing gums per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo lozenge
Two placebo lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo lozenges
The women participating in the study will take two placebo lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo capsule
Two placebo capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo capsules
The women participating in the study will take two placebo capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Interventions
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Probiotic lozenges
The women participating in the study will take two probiotic lozenges per day (morning and evening) after meals.Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo lozenges
The women participating in the study will take two placebo lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic capsules
The women participating in the study will take two probiotic capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo capsules
The women participating in the study will take two placebo capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Probiotic chewing gum
The women participating in the study will take two probiotic chewing gums per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maternal age \> or = 18 y
Exclusion Criteria
* Occlusive placenta previa, placenta previa in the anterior wall of the uterus, suspicion of accreta/increta/percreta infiltration
* Unable to understand information about the study due to language or severe mental disease
* Known Hepatitis B, C, HIV
* Known immunosuppressive illness if they are under treatment
* Treatment with cytokine, methotrexate or immunosuppresses cytotoxics in the last 6 months before the study.
* Gastro-intestinal surgery including gastric bypass or huge intestinal resection.
* Anaphylactic shock
* Uterus malformation that occludes cervical Canal or uterus segment.
18 Years
FEMALE
Yes
Sponsors
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BioGaia AB
INDUSTRY
Sahlgrenska University Hospital
OTHER
Responsible Party
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Bo Jacobsson
Clinical professor
Principal Investigators
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Bo Jacobsson, Professor
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Dnr. 085-15
Identifier Type: -
Identifier Source: org_study_id