Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women
Condition: Gestational Mother; Streptococcus Agalactiae Infection
MeSH terms: Streptococcal Infections
Study type: Interventional

Summary: 
      An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group
      study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius
      V4II-90 in the reduction of Group B Streptococcus (GBS) colonization in pregnant women who
      are GBS carriers. Forty GBS-positive participants in their first trimester of pregnancy will
      be randomly assigned to one of the two study groups: The experimental group with 3 months
      probiotic consumption; and the control group with 3 months placebo consumption. The efficacy
      of the probiotic strain to reduce the incidence of Group B Streptococcus will be assessed by
      the percentage of participants with a vaginal and/or rectal detection of Group B
      Streptococcus at the end of the study, by bilateral comparison of the treatment group with
      the control group at the same time period. The estimated duration of the study will be 30
      weeks, which includes a 3-month product administration. The intervention will start at week
      23 ± 4 days of pregnancy and end at week 35 ± 4 days. Then, a visit will be completed one
      month after delivery.
    

Detailed description: 
      All pregnant women reporting to the clinic in their first trimester of pregnancy (week 11 ± 2
      weeks of pregnancy) will be asked to participate in this study. Participation will be
      voluntary and written informed consent will be obtained from each participant. The study
      visits will take place in the hospital.

      At Visit 1, the inclusion and exclusion criteria will be verified. After signing the informed
      consent, a physical examination will be performed in addition to a vaginal-rectal smear to
      detect if they are GBS-positive. Information on the demographic profile and medical history
      will be collected. The investigator will explain to the participant that she cannot use any
      probiotic during the course of the study.

      At Visit 2, within 21-23 weeks ± 4 days of gestation, the inclusion and exclusion criteria
      will be reviewed. When a positive result of the microbiological analysis of the
      vaginal-rectal exudate are obtained, the pregnant GBS+ women will be invited to continue in
      the study. The randomized participant will intake one capsule of probiotic or placebo every
      day for the next 12 weeks. The participant will be given a diary and instructions to record
      the product intake. Adverse events occurring from the time of study inclusion will be
      recorded. Adverse Events occurring from the time of study inclusion will be recorded.

      At the third visit (Visit 3, 35 weeks ± 4 days of gestation), all participants continuing in
      the study will undergo a general physical examination. A sample of vaginal and rectal exudate
      will be collected from the participants who end the treatment period. Adverse Events
      occurring during the period between Visit 2 and Visit 3 will be recorded. The participants
      must deliver the remaining product and the completed diary.

      During Visit 4 (1 month after delivery), all participants will have a general physical
      examination. Adverse Events occurring since Visit 3 will be recorded. Data will be collected
      on the delivery and occurrence of early- or late-onset GBS sepsis in the newborn during the
      first month of life.
    

Intervention name(s): Lactobacillus salivarius V4II-90; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the Lactobacillus salivarius V4II-90 (1*10E9 CFU) probiotic supplement over a 12 weeks period. A visit will then be completed one month after delivery.; 7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the placebo supplement over a 12 weeks period. A visit will then be completed one month after delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an interventional randomized, multicenter, double-blind, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment