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

NCT03375125 | Unknown

• 1 other identifier: CSUB0138
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

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)

Conditions

Periodontitis and Pregnancy

Outcome Measures

Primary Outcomes (1)

• Improvement of periodontal disease

  Changes along the study in periodontal disease evaluated through Modified Gingival Index

  6 months

Secondary Outcomes (6)

• Prematurity risk reduction

  At delivery

• Mother Inflammosome profile

  6 months

• Placental Inflammosome

  At delivery

• Changes in vaginal microbiome

  6 months

• Intrauterine growth retardation (IUGR) risj reduction

  At delivery

Study Arms (2)

Probiotic

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Probiotic

Placebo OTHER

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)

Placebo

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovacion y Desarrollo de Estrategias en Salud: lead
• University of Bari: collaborator
• BioGaia AB: collaborator

Study Sites (2)

Department of Pediatric. Università di Bari; Ospedale Pediatrico Giovanni XXIII

Bari, 70121, Italy

NOT YET RECRUITING

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Related Publications (7)

• Krasse P, Carlsson B, Dahl C, Paulsson A, Nilsson A, Sinkiewicz G. Decreased gum bleeding and reduced gingivitis by the probiotic Lactobacillus reuteri. Swed Dent J. 2006;30(2):55-60.

  PMID: 16878680 RESULT

• Staab B, Eick S, Knofler G, Jentsch H. The influence of a probiotic milk drink on the development of gingivitis: a pilot study. J Clin Periodontol. 2009 Oct;36(10):850-6. doi: 10.1111/j.1600-051X.2009.01459.x. Epub 2009 Aug 12.

  PMID: 19682173 RESULT

• Harini PM, Anegundi RT. Efficacy of a probiotic and chlorhexidine mouth rinses: a short-term clinical study. J Indian Soc Pedod Prev Dent. 2010 Jul-Sep;28(3):179-82. doi: 10.4103/0970-4388.73799.

  PMID: 21157050 RESULT

• Slawik S, Staufenbiel I, Schilke R, Nicksch S, Weinspach K, Stiesch M, Eberhard J. Probiotics affect the clinical inflammatory parameters of experimental gingivitis in humans. Eur J Clin Nutr. 2011 Jul;65(7):857-63. doi: 10.1038/ejcn.2011.45. Epub 2011 Mar 30.

  PMID: 21448219 RESULT

• Iniesta M, Herrera D, Montero E, Zurbriggen M, Matos AR, Marin MJ, Sanchez-Beltran MC, Llama-Palacio A, Sanz M. Probiotic effects of orally administered Lactobacillus reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial. J Clin Periodontol. 2012 Aug;39(8):736-44. doi: 10.1111/j.1600-051X.2012.01914.x. Epub 2012 Jun 13.

  PMID: 22694350 RESULT

• Stensson M, Koch G, Coric S, Abrahamsson TR, Jenmalm MC, Birkhed D, Wendt LK. Oral administration of Lactobacillus reuteri during the first year of life reduces caries prevalence in the primary dentition at 9 years of age. Caries Res. 2014;48(2):111-7. doi: 10.1159/000354412. Epub 2013 Nov 29.

  PMID: 24296746 RESULT

• Toiviainen A, Jalasvuori H, Lahti E, Gursoy U, Salminen S, Fontana M, Flannagan S, Eckert G, Kokaras A, Paster B, Soderling E. Impact of orally administered lozenges with Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 on the number of salivary mutans streptococci, amount of plaque, gingival inflammation and the oral microbiome in healthy adults. Clin Oral Investig. 2015 Jan;19(1):77-83. doi: 10.1007/s00784-014-1221-6. Epub 2014 Mar 18.

  PMID: 24638207 RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research on Translational Research Center on Mother-Child Health

Model Details: Randomized controlled trial, double blind allocation concealment, parallel assignment

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 15, 2017
• Study Start: December 20, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ME (1)