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

Innovation and Development of Health Strategies

Status: Unknown

Conditions: Periodontitis and Pregnancy

Treatments: Dietary Supplement: Probiotic; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03375125

CSUB0138

Details and patient eligibility

About

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)

Full 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)

Enrollment: 300 estimated patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo