L. Reuteri ATCC PTA 5289 + L. Reuteri DSM 17938 in Pregnant Women
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| ClinicalTrials.gov Identifier: NCT03375125 |
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Recruitment Status : Unknown
Verified July 2019 by Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud.
Recruitment status was: Recruiting
First Posted : December 15, 2017
Last Update Posted : July 30, 2019
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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 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized 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 : | December 20, 2017 |
| Actual Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | December 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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
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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. |
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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)
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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) |
- Improvement of periodontal disease [ Time Frame: 6 months ]Changes along the study in periodontal disease evaluated through Modified Gingival Index
- Prematurity risk reduction [ Time Frame: At delivery ]Rate of prematurity at moment of delivery
- Mother Inflammosome profile [ Time Frame: 6 months ]Changes in salivary biomarkers of inflammation
- Placental Inflammosome [ Time Frame: At delivery ]Profile of cytokines measured in placenta at delivery
- Changes in vaginal microbiome [ Time Frame: 6 months ]Measurement of vaginal lactobacilli, bifidobacteria and streptococcus microbiome by RT-PCR
- Intrauterine growth retardation (IUGR) risj reduction [ Time Frame: At delivery ]Rate of Intrauterine growth retardation (IUGR) at delivery
- Newborn cord blood inflammosome [ Time Frame: At delivery ]Profile of cytokines measured in new-born cord blood at delivery
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| Ages Eligible for Study: | 15 Years to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375125
| Italy | |
| Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII | Not yet recruiting |
| Bari, Italy, 70121 | |
| Contact: Flavia Indrio, PhD +393292938421 f.indrio@alice.it | |
| Contact: Guisseppe Loverro, MD +393292938421 giuseppe.loverro@uniba.it | |
| Mexico | |
| Hospital General Dr. Manuel Gea Gonzalez | Recruiting |
| Mexico city, Tlalpan, Mexico, 14080 | |
| Contact: Cesar D Nieto, MSc 525540003000 ext 1246 cedav08@hotmail.com | |
| Contact: Paola Juarez, MD 525540003000 ext 1246 pao_8816@hotmail.com | |
| 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: | December 15, 2017 Key Record Dates |
| Last Update Posted: | July 30, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |