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L. Reuteri ATCC PTA 5289 + L. Reuteri DSM 17938 in Pregnant Women

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ClinicalTrials.gov Identifier: NCT03375125
Recruitment Status : Not yet recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
University of Bari
BioGaia AB
Information provided by (Responsible Party):
Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

Brief Summary:

Randomized controlled tril to evaluate the safety and efficacy for the combination of L. reuteri ATCC PTA 5289 & L. reuteri DSM 17938 in pregnant women with periodontitis and/or gingivits to improve oral health and at the same time reduce the risk for prematurity or intrauterine growth retardation (IUGR).

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)


Condition or disease Intervention/treatment Phase
Periodontitis and Pregnancy Dietary Supplement: Probiotic Other: Placebo Not Applicable

Detailed Description:

Rationale. Gingivitis and periodontitis represent highly prevalent oral pathologies in pregnant women. The physiological, immunological and endocrine changes imposed by pregnancy are associated with a greater predisposition for the development of gingivitis. Considering the potential association between the presence of gingivitis and the development of complications during pregnancy and the time of delivery (preeclampsia, preterm, IUGRs), it is important to evaluate the impact of early administration of a mixture of lactobacillus on improved health oral status, and at the same time assessing the effect on risk reduction of prematurity and/or IUGRs.

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial, double blind allocation concealment, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
Primary Purpose: Treatment
Official Title: Safety and Efficacy of L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 in Pregnant Women to Improve Oral Health and Reduce the Risk for Prematurity or Intrauterine Growth Retardation (IUGR)
Estimated Study Start Date : December 20, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : November 30, 2018

Arm Intervention/treatment
Experimental: 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
Dietary Supplement: 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 Comparator: 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)
Other: 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)




Primary Outcome Measures :
  1. Improvement of periodontal disease [ Time Frame: 6 months ]
    Changes along the study in periodontal disease evaluated through Modified Gingival Index


Secondary Outcome Measures :
  1. Prematurity risk reduction [ Time Frame: At delivery ]
    Rate of prematurity at moment of delivery

  2. Mother Inflammosome profile [ Time Frame: 6 months ]
    Changes in salivary biomarkers of inflammation

  3. Placental Inflammosome [ Time Frame: At delivery ]
    Profile of cytokines measured in placenta at delivery

  4. Changes in vaginal microbiome [ Time Frame: 6 months ]
    Measurement of vaginal lactobacilli, bifidobacteria and streptococcus microbiome by RT-PCR

  5. Intrauterine growth retardation (IUGR) risj reduction [ Time Frame: At delivery ]
    Rate of Intrauterine growth retardation (IUGR) at delivery

  6. Newborn cord blood inflammosome [ Time Frame: At delivery ]
    Profile of cytokines measured in new-born cord blood at delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy pregnant women
  • 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:

  • Pathologic pregnancy (except for preeclampsia and/or bacteriuria)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375125


Locations
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Italy
Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII Not yet recruiting
Bari, Italy, 70121
Contact: Flavia Indrio, PhD    +393292938421    f.indrio@alice.it   
Contact: Guisseppe Loverro, MD    +393292938421    giuseppe.loverro@uniba.it   
Mexico
Hospital General Dr. Manuel Gea Gonzalez
Mexico city, Tlalpan, Mexico, 14080
Sponsors and Collaborators
Innovacion y Desarrollo de Estrategias en Salud
University of Bari
BioGaia AB

Publications of Results:

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Responsible Party: Pedro Gutierrez Castrellon, Head of Research on Translational Research Center on Mother-Child Health, Innovacion y Desarrollo de Estrategias en Salud
ClinicalTrials.gov Identifier: NCT03375125     History of Changes
Other Study ID Numbers: CSUB0138
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontitis
Fetal Growth Retardation
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes