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Dose–Response Efficacy of a Proprietary Probiotic Formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for Antibiotic-Associated Diarrhea and Clostridium difficile-Associated Diarrhea Prophylaxis in Adult Patients

The American Journal of Gastroenterology volume 105, pages 16361641 (2010) | Download Citation



Standard therapies for antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) have limited efficacy. Probiotic prophylaxis is a promising alternative for reduction of AAD and CDAD incidence.


In this single-center, randomized, double-blind, placebo-controlled dose-ranging study, we randomized 255 adult inpatients to one of three groups: two probiotic capsules per day (Pro-2, n=86), one probiotic capsule and one placebo capsule per day (Pro-1, n=85), or two placebo capsules per day (n=84). Each probiotic capsule contained 50 billion c.f.u. of live organisms (Lactobacillus acidophilus CL1285® +Lactobacillus casei LBC80R® Bio-K+ CL1285). Probiotic prophylaxis began within 36 h of initial antibiotic administration, continued for 5 days after the last antibiotic dose, and patients were followed for an additional 21 days.


Pro-2 (15.5%) had a lower AAD incidence vs. Pro-1 (28.2%). Each probiotic group had a lower AAD incidence vs. placebo (44.1%). In patients who acquired AAD, Pro-2 (2.8 days) and Pro-1 (4.1 days) had shorter symptom duration vs. placebo (6.4 days). Similarly, Pro-2 (1.2%) had a lower CDAD incidence vs. Pro-1 (9.4%). Each treatment group had a lower CDAD incidence vs. placebo (23.8%). Gastrointestinal symptoms were less common in the treatment groups vs. placebo and in Pro-2 vs. Pro-1.


The proprietary probiotic blend used in this study was well tolerated and effective for reducing risk of AAD and, in particular, CDAD in hospitalized patients on antibiotics. A dose-ranging effect was shown with 100 billion c.f.u., yielding superior outcomes and fewer gastrointestinal events compared to 50 billion c.f.u. (ClinicalTrials.gov number NCT00958308).

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We thank Charlie Zhang, MD, and Kelly Zhang, RN, of Sprim Advanced Life Sciences for their help with study conduct and data collection.

Author information


  1. Department of Gastroenterology, Xinhua/Yuyao Hospital, Shanghai, China

    • Xing Wang Gao
    •  & Chong Yu Fang
  2. Sprim Advanced Life Sciences, San Francisco, California, USA

    • Mohamed Mubasher
    • , Cheryl Reifer
    •  & Larry E Miller


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Competing interests

Guarantor of the article: Xing Wang Gao, MD.

Specific author contributions: Planning study: Xing Wang Gao, Mohamed Mubasher, Chong Yu Fang, and Cheryl Reifer; conducting study: Xing Wang Gao, Chong Yu Fang, and Cheryl Reifer; collecting data: Xing Wang Gao and Chong Yu Fang; interpreting data: Xing Wang Gao, Mohamed Mubasher, and Larry E. Miller; drafting paper: Xing Wang Gao, Mohamed Mubasher, Cheryl Reifer, and Larry E. Miller; approval of submitted final draft: Xing Wang Gao, Mohamed Mubasher, Chong Yu Fang, Cheryl Reifer, and Larry E. Miller.

Financial support: Bio-K+ International (Laval, Quebec, Canada) provided financial support for this clinical trial. Sprim Advanced Life Sciences helped with study planning, conduct, and analysis and with paper development.

Potential competing interests: None.

Corresponding author

Correspondence to Larry E Miller.

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