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

Sponsor

Innovacion y Desarrollo de Estrategias en Salud (Other)

Overall Status

Unknown status

CT.gov ID

NCT03375125

Collaborator

University of Bari (Other), BioGaia AB (Industry)

300

Enrollment

Locations

Arms

24.3

Anticipated Duration (Months)

150

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Periodontitis and Pregnancy	Dietary Supplement: Probiotic Other: Placebo	N/A

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 &

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial, double blind allocation concealment, parallel assignmentRandomized controlled trial, double blind allocation concealment, parallel assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 20, 2017

Actual Primary Completion Date :

Jun 30, 2019

Anticipated Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic 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	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.
Placebo Comparator: 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)	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)

Arm

Intervention/Treatment

Experimental: Probiotic

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

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.

Placebo Comparator: 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)

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)

Outcome Measures

Primary Outcome Measures

Improvement of periodontal disease [6 months]
Changes along the study in periodontal disease evaluated through Modified Gingival Index

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Innovacion y Desarrollo de Estrategias en Salud
University of Bari
BioGaia AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pedro Gutierrez Castrellon, Head of Research on Translational Research Center on Mother-Child Health, Innovacion y Desarrollo de Estrategias en Salud

ClinicalTrials.gov Identifier:

NCT03375125

Other Study ID Numbers:

CSUB0138

First Posted:

Dec 15, 2017

Last Update Posted:

Jul 30, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Jul 30, 2019