Periodontitis and Pregnancy Clinical Trial
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)
| Verified date | July 2019 |
| Source | Innovacion y Desarrollo de Estrategias en Salud |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 30, 2019 |
| Est. primary completion date | June 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 15 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII | Bari | |
| Mexico | Hospital General Dr. Manuel Gea Gonzalez | Mexico city | Tlalpan |
| Lead Sponsor | Collaborator |
|---|---|
| Innovacion y Desarrollo de Estrategias en Salud | BioGaia AB, University of Bari |
Italy, Mexico,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement of periodontal disease | Changes along the study in periodontal disease evaluated through Modified Gingival Index | 6 months | |
| Secondary | Prematurity risk reduction | Rate of prematurity at moment of delivery | At delivery | |
| Secondary | Mother Inflammosome profile | Changes in salivary biomarkers of inflammation | 6 months | |
| Secondary | Placental Inflammosome | Profile of cytokines measured in placenta at delivery | At delivery | |
| Secondary | Changes in vaginal microbiome | Measurement of vaginal lactobacilli, bifidobacteria and streptococcus microbiome by RT-PCR | 6 months | |
| Secondary | Intrauterine growth retardation (IUGR) risj reduction | Rate of Intrauterine growth retardation (IUGR) at delivery | At delivery | |
| Secondary | Newborn cord blood inflammosome | Profile of cytokines measured in new-born cord blood at delivery | At delivery |