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MIAMI — A proprietary probiotic combination of two live Lactobacillus organisms significantly reduced the incidence and severity of antibiotic-associated diarrhea, as well as the incidence of Clostridium difficile–associated diarrhea, compared with placebo in a prospective, double-blind study.
Researchers at Shanghai Jiao Tong University in China randomized 255 hospitalized patients, aged 50–70 years, within 36 hours of antibiotic initiation to one of three groups: 86 patients took two probiotic capsules daily, 85 took one probiotic capsule plus one placebo capsule daily, and 84 took two placebo capsules daily. Each capsule contained 50 billion colony forming units (c.f.u.) of L. acidophilus CL1285 and L. casei LBC80R (made by Bio-K Plus International, which funded the trial). The regimen continued for 5 days after the usual course of antibiotics, then patients were monitored for another 21days.
The incidence of antibiotic-associated diarrhea–the primary study outcome—was 29% overall, affecting 74 patients. Specifically, diarrhea occurred in 16% of the patients who took two active capsules, 28% of those who took one active and one placebo capsule, and 44% of those who took two placebo capsules. Controlled comparisons were statistically significant between the groups, suggesting a dose-response relationship, Kerry Diaz said in an interview at a poster presentation.
The second outcome, severity of diarrhea, was likewise lower with the 100 billion c.f.u. daily dose. The researchers tracked the mean number of days that patients reported three or more episodes of liquid to soft stool. Patients in the high-dose probiotic group had a mean 2.8 days of severe diarrhea, compared with 4.1 days for those in the low-dose group and 6.4 days in the placebo group. Again, the differences were statistically different.
The researchers also found a significant difference in the incidence of C. difficile—associated diarrhea: 1% in the high-dose probiotic group, 9% in the low-dose group, and 24% in the placebo cohort—a “huge difference,” Ms. Diaz said. The full study findings were published earlier this year (Am. J. Gastroenterol. 2010 Feb. 9 [doi:10.1038/ajg.2010.11
The product is sold as a supplement in the United States, Ms. Diaz said, and has been available for more than a decade in Quebec, where Bio-K Plus is based. The product has not been reviewed by the U.S. Food and Drug Administration for antibiotic-associated and C. difficile—associated diarrhea, she added.
Disclosures: Ms. Diaz is a clinical research manager at Bio-K Plus International.
MIAMI — A proprietary probiotic combination of two live Lactobacillus organisms significantly reduced the incidence and severity of antibiotic-associated diarrhea, as well as the incidence of Clostridium difficile–associated diarrhea, compared with placebo in a prospective, double-blind study.
Researchers at Shanghai Jiao Tong University in China randomized 255 hospitalized patients, aged 50–70 years, within 36 hours of antibiotic initiation to one of three groups: 86 patients took two probiotic capsules daily, 85 took one probiotic capsule plus one placebo capsule daily, and 84 took two placebo capsules daily. Each capsule contained 50 billion colony forming units (c.f.u.) of L. acidophilus CL1285 and L. casei LBC80R (made by Bio-K Plus International, which funded the trial). The regimen continued for 5 days after the usual course of antibiotics, then patients were monitored for another 21days.
The incidence of antibiotic-associated diarrhea–the primary study outcome—was 29% overall, affecting 74 patients. Specifically, diarrhea occurred in 16% of the patients who took two active capsules, 28% of those who took one active and one placebo capsule, and 44% of those who took two placebo capsules. Controlled comparisons were statistically significant between the groups, suggesting a dose-response relationship, Kerry Diaz said in an interview at a poster presentation.
The second outcome, severity of diarrhea, was likewise lower with the 100 billion c.f.u. daily dose. The researchers tracked the mean number of days that patients reported three or more episodes of liquid to soft stool. Patients in the high-dose probiotic group had a mean 2.8 days of severe diarrhea, compared with 4.1 days for those in the low-dose group and 6.4 days in the placebo group. Again, the differences were statistically different.
The researchers also found a significant difference in the incidence of C. difficile—associated diarrhea: 1% in the high-dose probiotic group, 9% in the low-dose group, and 24% in the placebo cohort—a “huge difference,” Ms. Diaz said. The full study findings were published earlier this year (Am. J. Gastroenterol. 2010 Feb. 9 [doi:10.1038/ajg.2010.11
The product is sold as a supplement in the United States, Ms. Diaz said, and has been available for more than a decade in Quebec, where Bio-K Plus is based. The product has not been reviewed by the U.S. Food and Drug Administration for antibiotic-associated and C. difficile—associated diarrhea, she added.
Disclosures: Ms. Diaz is a clinical research manager at Bio-K Plus International.
MIAMI — A proprietary probiotic combination of two live Lactobacillus organisms significantly reduced the incidence and severity of antibiotic-associated diarrhea, as well as the incidence of Clostridium difficile–associated diarrhea, compared with placebo in a prospective, double-blind study.
Researchers at Shanghai Jiao Tong University in China randomized 255 hospitalized patients, aged 50–70 years, within 36 hours of antibiotic initiation to one of three groups: 86 patients took two probiotic capsules daily, 85 took one probiotic capsule plus one placebo capsule daily, and 84 took two placebo capsules daily. Each capsule contained 50 billion colony forming units (c.f.u.) of L. acidophilus CL1285 and L. casei LBC80R (made by Bio-K Plus International, which funded the trial). The regimen continued for 5 days after the usual course of antibiotics, then patients were monitored for another 21days.
The incidence of antibiotic-associated diarrhea–the primary study outcome—was 29% overall, affecting 74 patients. Specifically, diarrhea occurred in 16% of the patients who took two active capsules, 28% of those who took one active and one placebo capsule, and 44% of those who took two placebo capsules. Controlled comparisons were statistically significant between the groups, suggesting a dose-response relationship, Kerry Diaz said in an interview at a poster presentation.
The second outcome, severity of diarrhea, was likewise lower with the 100 billion c.f.u. daily dose. The researchers tracked the mean number of days that patients reported three or more episodes of liquid to soft stool. Patients in the high-dose probiotic group had a mean 2.8 days of severe diarrhea, compared with 4.1 days for those in the low-dose group and 6.4 days in the placebo group. Again, the differences were statistically different.
The researchers also found a significant difference in the incidence of C. difficile—associated diarrhea: 1% in the high-dose probiotic group, 9% in the low-dose group, and 24% in the placebo cohort—a “huge difference,” Ms. Diaz said. The full study findings were published earlier this year (Am. J. Gastroenterol. 2010 Feb. 9 [doi:10.1038/ajg.2010.11
The product is sold as a supplement in the United States, Ms. Diaz said, and has been available for more than a decade in Quebec, where Bio-K Plus is based. The product has not been reviewed by the U.S. Food and Drug Administration for antibiotic-associated and C. difficile—associated diarrhea, she added.
Disclosures: Ms. Diaz is a clinical research manager at Bio-K Plus International.