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

NCT03375125 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-07-30

No results posted yet for this study

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)

Conditions

  • Periodontitis and Pregnancy

Interventions

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.

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)

Sponsors & Collaborators

  • University of Bari

    collaborator OTHER

  • BioGaia AB

    collaborator INDUSTRY

  • Innovacion y Desarrollo de Estrategias en Salud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2019-06-30
Completion
2019-12-30

Countries

  • Italy
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375125 on ClinicalTrials.gov