OBJECTIVE: To examine the effect of an oral prenatal probiotic on group B Streptococcus (GBS) colonization and to demonstrate the feasibility of a larger randomized controlled trial. DESIGN: This pilot study was an open-label, two-group quasi-experiment. SETTING: An urban central city nurse-midwifery and wellness center serving a diverse population. PARTICIPANTS: Ten pregnant participants received the oral probiotic (Florajen3) taken once daily, and 10 participants served as controls. METHODS: A questionnaire on dietary practices, vaginal cleansing, sexual history, and symptoms and GBS colony count samples were taken at 28-, 32-, and 36-weeks gestation. RESULTS: Participants in the probiotic group reported no adverse events or minor side effects; one half reported improved gastrointestinal symptoms. Although two women in each group had positive qualitative prenatal GBS cultures at 36 weeks, the probiotic group participants had lower quantitative GBS colony counts. The eight GBS negative averaged 90% probiotic adherence compared with two GBS positive women who averaged 68%. Yogurt ingestion was inversely related (p = .02) to GBS colonization. CONCLUSIONS:Prenatal probiotic therapy has the potential to reduce GBS colonization. The potential of the probiotic intervention appears to be linked to daily adherence. A controlled clinical trial with a larger, adequately powered sample is feasible and justified.
RCT Entities:
OBJECTIVE: To examine the effect of an oral prenatal probiotic on group B Streptococcus (GBS) colonization and to demonstrate the feasibility of a larger randomized controlled trial. DESIGN: This pilot study was an open-label, two-group quasi-experiment. SETTING: An urban central city nurse-midwifery and wellness center serving a diverse population. PARTICIPANTS: Ten pregnant participants received the oral probiotic (Florajen3) taken once daily, and 10 participants served as controls. METHODS: A questionnaire on dietary practices, vaginal cleansing, sexual history, and symptoms and GBS colony count samples were taken at 28-, 32-, and 36-weeks gestation. RESULTS:Participants in the probiotic group reported no adverse events or minor side effects; one half reported improved gastrointestinal symptoms. Although two women in each group had positive qualitative prenatal GBS cultures at 36 weeks, the probiotic group participants had lower quantitative GBS colony counts. The eight GBS negative averaged 90% probiotic adherence compared with two GBS positive women who averaged 68%. Yogurt ingestion was inversely related (p = .02) to GBS colonization. CONCLUSIONS: Prenatal probiotic therapy has the potential to reduce GBS colonization. The potential of the probiotic intervention appears to be linked to daily adherence. A controlled clinical trial with a larger, adequately powered sample is feasible and justified.
Authors: Kathryn A Patras; Philip A Wescombe; Berenice Rösler; John D Hale; John R Tagg; Kelly S Doran Journal: Infect Immun Date: 2015-06-15 Impact factor: 3.441