An interventional study of Probiotic and Placebo in Periodontitis and Pregnancy, sponsored by Innovacion y Desarrollo de Estrategias en Salud. Status unknown at 2 sites in 2 countries. Open to female participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Innovacion y Desarrollo de Estrategias en Salud · Not applicable, Interventional, and Treatment
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)
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)
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 300 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Innovacion y Desarrollo de Estrategias en Salud is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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
Changes along the study in periodontal disease evaluated through Modified Gingival Index
Time frame: 6 months
Prematurity risk reduction
Rate of prematurity at moment of delivery
Time frame: At delivery
Mother Inflammosome profile
Changes in salivary biomarkers of inflammation
Time frame: 6 months
Placental Inflammosome
Profile of cytokines measured in placenta at delivery
Time frame: At delivery
Changes in vaginal microbiome
Measurement of vaginal lactobacilli, bifidobacteria and streptococcus microbiome by RT-PCR
Time frame: 6 months
Intrauterine growth retardation (IUGR) risj reduction
Rate of Intrauterine growth retardation (IUGR) at delivery
Time frame: At delivery
Newborn cord blood inflammosome
Profile of cytokines measured in new-born cord blood at delivery
Time frame: At delivery
Plan to share: No
Ran from Dec 2017 to primary completion in Jun 2019, 18 months.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 18 months is above that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
Innovacion y Desarrollo de Estrategias en Salud