L. Reuteri ATCC PTA 5289 + L. Reuteri DSM 17938 in Pregnant Women
NCT ID: NCT03375125
Last Updated: 2019-07-30
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-12-20
2019-12-30
Brief Summary
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Women in this study wil receive L. reuteri Prodentis (L. reuteri DSM 17938 \& L. reuteri ATCC PTA 5289 ) at a dose of 2x10\^8 Colony Forming Units (CFU). One lozenges is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day since randomization until delivery. The control group will receive placebo lozenges which contains identical ingredients except for lacking the bacteria. One lozenges is to be taken twice per day (one in the morning and one in the afternoon. The study product will be kept refrigerated (+20 - +80 C)
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Detailed Description
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For primary outcome the investigators will evaluate the changes along the study in the oral health status evaluated through a composite of Modified Gingival Index (Lobene) + Plaque Index (Silnes and Loe) + Gingival Bleeding Index + Probing pocket depth (PPD) and Clinical attachment level (CAL).
For secondary outcomes the investigators will evaluate rate of prematurity and or Intrauterine growth retardation; changes in mother salivary markers of systemic inflammation; profile of inflammosome in placenta and new born cord blood; lactobacilli, bifidobacteria and streptococcus profile in vagina by RT-PCR (specific primers); changes during the study for oral microbiome Intervention group wil receive L. reuteri Prodentis (L. reuteri DSM 17938 \& L. reuteri ATCC PTA 5289 ) at a dose of 2x10\^8 Colony Forming Units (CFU). One lozenges is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day since randomization until delivery.
The control group will receive placebo lozenges which contains identical ingredients except for lacking the bacteria. One lozenges is to be taken twice per day (one in the morning and one in the afternoon. The study product will be kept refrigerated (+20 - +80 C)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289), dose of 2x10\^8 Colony Forming Units (CFU). One lozenges will be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day
Probiotic
L. reuteri DSM 17938 \& L. reuteri ATCC PTA 5289 ) will be given at a dose of 2x10\^8 Colony Forming Units (CFU). One lozenges is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day.
Placebo
Placebo will have identical appearance, taste, and flavor, except for lacking the bacteria. One lozenges will be taken twice per day (one in the morning and one in the afternoon)
Placebo
Placebo will have identical appearance, taste, and flavor, except for lacking the bacteria. One lozenges will be taken twice per day (one in the morning and one in the afternoon)
Interventions
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Probiotic
L. reuteri DSM 17938 \& L. reuteri ATCC PTA 5289 ) will be given at a dose of 2x10\^8 Colony Forming Units (CFU). One lozenges is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day.
Placebo
Placebo will have identical appearance, taste, and flavor, except for lacking the bacteria. One lozenges will be taken twice per day (one in the morning and one in the afternoon)
Eligibility Criteria
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Inclusion Criteria
* Age (Italy: 18-40 years; Mexico: 15-40 years)
* Gestational week (Mexico: \>8 weeks and 16 weeks; Italy: \>8 weeks and 12 weeks)
* Mild to Severe Gingival and Periodontal disease verified by dentist using Lobene Modified Gingival Index, Plaque Index, Gingival Bleeding Index, probing pocket depth (PPD) and clinical attachment level (CAL)
* Signed Informed consent
Exclusion Criteria
* Severe obesity (Body Mass Index\>35)
* Use of any product containing probiotics 2 weeks before randomization
* Use of any product containing chlorhexidine 2 weeks before randomization
* Antibiotic therapy within 2 weeks before randomization
* Known allergies towards the ingredients of the experimental product
* Inability to comprehend to the study protocol
* Systemic diseases differnt that periodontal disease
15 Years
40 Years
FEMALE
No
Sponsors
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University of Bari
OTHER
BioGaia AB
INDUSTRY
Innovacion y Desarrollo de Estrategias en Salud
OTHER
Responsible Party
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Pedro Gutierrez Castrellon
Head of Research on Translational Research Center on Mother-Child Health
Locations
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Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII
Bari, , Italy
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, Mexico
Countries
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Facility Contacts
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References
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Krasse P, Carlsson B, Dahl C, Paulsson A, Nilsson A, Sinkiewicz G. Decreased gum bleeding and reduced gingivitis by the probiotic Lactobacillus reuteri. Swed Dent J. 2006;30(2):55-60.
Staab B, Eick S, Knofler G, Jentsch H. The influence of a probiotic milk drink on the development of gingivitis: a pilot study. J Clin Periodontol. 2009 Oct;36(10):850-6. doi: 10.1111/j.1600-051X.2009.01459.x. Epub 2009 Aug 12.
Harini PM, Anegundi RT. Efficacy of a probiotic and chlorhexidine mouth rinses: a short-term clinical study. J Indian Soc Pedod Prev Dent. 2010 Jul-Sep;28(3):179-82. doi: 10.4103/0970-4388.73799.
Slawik S, Staufenbiel I, Schilke R, Nicksch S, Weinspach K, Stiesch M, Eberhard J. Probiotics affect the clinical inflammatory parameters of experimental gingivitis in humans. Eur J Clin Nutr. 2011 Jul;65(7):857-63. doi: 10.1038/ejcn.2011.45. Epub 2011 Mar 30.
Iniesta M, Herrera D, Montero E, Zurbriggen M, Matos AR, Marin MJ, Sanchez-Beltran MC, Llama-Palacio A, Sanz M. Probiotic effects of orally administered Lactobacillus reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial. J Clin Periodontol. 2012 Aug;39(8):736-44. doi: 10.1111/j.1600-051X.2012.01914.x. Epub 2012 Jun 13.
Stensson M, Koch G, Coric S, Abrahamsson TR, Jenmalm MC, Birkhed D, Wendt LK. Oral administration of Lactobacillus reuteri during the first year of life reduces caries prevalence in the primary dentition at 9 years of age. Caries Res. 2014;48(2):111-7. doi: 10.1159/000354412. Epub 2013 Nov 29.
Toiviainen A, Jalasvuori H, Lahti E, Gursoy U, Salminen S, Fontana M, Flannagan S, Eckert G, Kokaras A, Paster B, Soderling E. Impact of orally administered lozenges with Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 on the number of salivary mutans streptococci, amount of plaque, gingival inflammation and the oral microbiome in healthy adults. Clin Oral Investig. 2015 Jan;19(1):77-83. doi: 10.1007/s00784-014-1221-6. Epub 2014 Mar 18.
Other Identifiers
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CSUB0138
Identifier Type: -
Identifier Source: org_study_id
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