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

Not Applicable

• Conditions: Periodontitis and Pregnancy

• Registration Number: NCT03375125
• Lead Sponsor: 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)

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)

Study Timeline

• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Study Start: 2017-12-20
• Primary Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-27
• Last Update Posted: 2019-07-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of periodontal disease	6 months	Changes along the study in periodontal disease evaluated through Modified Gingival Index

Secondary Outcome Measures

Name	Time	Method
Prematurity risk reduction	At delivery	Rate of prematurity at moment of delivery
Mother Inflammosome profile	6 months	Changes in salivary biomarkers of inflammation
Placental Inflammosome	At delivery	Profile of cytokines measured in placenta at delivery
Changes in vaginal microbiome	6 months	Measurement of vaginal lactobacilli, bifidobacteria and streptococcus microbiome by RT-PCR
Intrauterine growth retardation (IUGR) risj reduction	At delivery	Rate of Intrauterine growth retardation (IUGR) at delivery
Newborn cord blood inflammosome	At delivery	Profile of cytokines measured in new-born cord blood at delivery

Trial Locations

Locations (2)

Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII; 🇮🇹 Bari, Italy

Hospital General Dr. Manuel Gea Gonzalez; 🇲🇽 Mexico city, Tlalpan, Mexico