Program Schedule

1681
Randomized Clinical Trial of the Recovery of Probiotics Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis subspecies lactis (BB-12) from the Gastrointestinal (GI) Tract of Healthy Volunteers

Session: Poster Abstract Session: Microbial and Host Factors
Saturday, October 11, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • Poutsiaka LGG-BB12 poster abstr#46750 present# 1681 FINAL 090914.pdf (217.5 kB)
  • Background: Probiotics are live microorganisms that confer a health benefit when ingested.  The dietary supplement ProNutrients® Probiotic contains the probiotics LGG and BB-12 in a powder sachet.  The objectives of this study were to confirm the survival and recovery of the organisms from the GI tract of healthy volunteers after ingestion of the supplement and to assess safety.

    Methods: This was a 2 arm, parallel group, open label randomized prospective study of healthy volunteers.  All subjects underwent a run-in period (> 14 d). Thereafter, the subjects were randomized to a non-supplemented control group (C) or the probiotic (P) group, which consumed 1 sachet of supplement (S) containing > 1x109 colony forming units (CFU) of each organism/day for 21 d. There was a 28 d post-S period.  Fecal samples were collected at baseline (the end of the run-in period), and after 14, 21, and 28 d. LGG and BB-12 were quantified by (1) quantitative culture (qCX) with colony ID confirmed by polymerase chain reaction (PCR) and (2) qPCR.  The primary endpoint was the recovery of LGG and BB-12 (CFU/g) from the fecal samples of all subjects at 21 d. CFU were log10 transformed.  Paired t-tests were used to compare within subjects change from baseline.  ANOVA models with a treatment term were used to compare groups.

    Results: 27 subjects (13 males and 14 females) were randomized and included in the analysis. The Table shows results for recovery of LGG and BB-12 by qCX at 21 d.  Similar results were obtained at 14 d and for recovery by qPCR at 14 and 21 d.

     

    LGG

    BB-12

    P

    N=19

    C

    N=8

    P

    N=19

    C

    N=8

    Baseline

      Mean (SD) log10 CFU/g sample

    3.5 (0.6)

    3.4* (0.0)

    5.4 (0.0)

    5.4* (0.0)

    21 days after baseline

      Mean (SD)

    5.5 (1.7)

    3.4* (0.0)

    7.2 (1.1)

    5.4* (0.0)

    p-value 21 d vs baseline

    < 0.001

    -

    < 0.001

    -

    p-value P vs C

    0.006

    <0.001

    *Lower limit of detection.

    6 subjects (31.6%), all in the P group, reported 14 mild and 7 moderate severity adverse events (AE).  The 2 treatment-related AEs were mild: diarrhea and abdominal distension, each in 1 subject. 

    Conclusion: Few studies have examined the recovery of viable organisms after ingestion of probiotic combinations. Here we demonstrate the recovery of viable LGG and BB-12 from the GI tract of healthy volunteers who consumed this probiotic product matrix.  The supplement was well tolerated.

    Debra D. Poutsiaka, MD, PhD, FIDSA1, Lisa E. Davidson, MD1, Lori Lathrop Stern, PhD, RD2, Cheleste M. Thorpe, MD1, Anne V. Kane, MD1, Ian J. Mahoney, BA1, Laura Mcdermott, BS1, Rina Leyva, MS2, Barry Goldin, PhD3 and David R. Snydman, MD, FIDSA1, (1)Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, MA, (2)Pfizer Consumer Healthcare, Madison, NJ, (3)Tufts University School of Medicine, Boston, MA

    Disclosures:

    D. D. Poutsiaka, Pfizer Consumer Healthcare: Investigator, Research support

    L. E. Davidson, Pfizer Consumer Healthcare: Investigator, Research support

    L. Lathrop Stern, Pfizer Consumer Healthcare: Investigator, Research support

    C. M. Thorpe, Pfizer Consumer Healthcare: Investigator, Research support

    A. V. Kane, Pfizer Consumer Healthcare: Investigator, Research support

    I. J. Mahoney, None

    L. Mcdermott, None

    R. Leyva, Pfizer Consumer Healthcare: Employee, Salary

    B. Goldin, None

    D. R. Snydman, Pfizer Consumer Healthcare: Investigator, Research support

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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