Status:
UNKNOWN
L. Reuteri ATCC PTA 5289 + L. Reuteri DSM 17938 in Pregnant Women
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Collaborating Sponsors:
University of Bari
BioGaia AB
Conditions:
Periodontitis and Pregnancy
Eligibility:
FEMALE
15-40 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03375125
Start Date
December 20 2017
End Date
December 30 2019
Last Update
July 30 2019
Active Locations (2)
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1
Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII
Bari, Italy, 70121
2
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, Mexico, 14080