Home Ingredients Bio-K+® (Three-Strain Lactobacillus Probiotic Blend)

Bio-K+® (Three-Strain Lactobacillus Probiotic Blend)

Evidence Level
Limited
6 Clinical Trials
4 Documented Benefits
2/5 Evidence Score

Bio-K+® is a probiotic made in Laval, Quebec, by Bio-K Plus International, now a Kerry company. Most of its products use three strains, Lactobacillus acidophilus CL1285, Lacticaseibacillus casei LBC80R and Lacticaseibacillus rhamnosus CLR2, in dairy and plant-based fermented drinks and capsules. In three placebo-controlled trials in adults taking antibiotics, mostly in hospital, the fermented milk or capsules were followed by less antibiotic-associated diarrhea in two; in the third the lower rate was not significant. The maker sponsored or funded two of them, which named only the first two strains. A maker-sponsored trial in adults with irritable bowel syndrome missed its primary outcome, and an Alberta hospital rollout found no change in hospital-acquired C. difficile infection. As the favorable trials were in people taking antibiotics, this page has no benefit category.

Studied Dose In hospital trials, one or two 50 billion CFU capsules a day (two did better) or 98 g a day of fermented milk with 50 billion CFU, from within 24 to 36 hours of the first antibiotic dose until 5 days after the last. In adults with bowel complaints, two capsules a day for 12 weeks.
Active Compound Live cells of three lactic acid bacteria strains: Lactobacillus acidophilus CL1285, Lacticaseibacillus casei LBC80R and Lacticaseibacillus rhamnosus CLR2. The maker lists a minimum of 50 billion live bacteria per bottle of its standard dairy and vegan drinks, 80 billion in some vegan drinks with added ingredients, 12.5 billion in its shots and kids' drink, and 12.5 to 80 billion CFU per capsule, depending on the product. The maker says most, not all, of its products use these three strains; some Bio-K+ products are built on other strains, such as Limosilactobacillus reuteri LRC or L. fermentum LC40. The hospital trials published from 2007 to 2010 described the product as L. acidophilus CL1285 plus L. casei (LBC80R) and did not name CLR2.

Benefits

Digestive support during antibiotic courses in hospitalized adults

In 255 inpatients on antibiotics, one or two 50 billion CFU capsules a day were followed by less antibiotic-associated diarrhea than placebo (28.2% and 15.5% vs 44.1%), and in 89 inpatients the fermented milk gave 15.9% vs 35.6%. In 437 adults the rate was 21.8% vs 29.4% (not significant), with fewer diarrhea days. The maker sponsored or funded two trials.

Supported by Trial 1, Trial 2

Gut support in hospital programs pairing the blend with antibiotics

A Quebec hospital that gave the blend to all adult inpatients on antibiotics saw C. difficile infection rates fall and stay below similar hospitals, without a randomized comparison. A Chicago-area before-and-after study found no overall change, with low adherence, and a cluster-randomized rollout in 4 Alberta hospitals found no change in hospital-acquired cases.

Supported by Trial 5

Bowel habits and quality of life in adults with bowel complaints

In a 12-week placebo-controlled trial in 113 adults with irritable bowel syndrome, two capsules a day did not improve adequate relief, the registered primary outcome, or pain intensity. Stool and quality of life scores favored the probiotic in some subgroups, mainly diarrhea-predominant cases and women. The maker sponsored the trial.

Supported by Trial 4, Trial 1

Hand skin and itch in a 12-week single-group study

In an open study without a control group, 30 adults with chronic hand dermatitis took one 30 billion CFU capsule a day alongside topical care for 12 weeks. Of 22 who finished, clinicians rated 19 improved, and 23% of participants reached clear or almost clear hands. The maker funded the investigators, so the result needs a controlled trial.

Supported by Trial 6

Mechanism of action

1

Two strains in older papers, three in newer ones

Hospital trials from 2007 to 2010 and a 2013 hospital report describe the product as L. acidophilus CL1285 plus L. casei LBC80R, while papers from 2015 on, including maker-authored ones, name a third strain, L. rhamnosus CLR2, and state the formula has been sold since 1996. The sources do not explain the difference, so each result here names the strains its paper lists.

2

Laboratory activity against a toxin-producing gut bacterium

In laboratory tests reported by maker scientists, the individual strains and finished products inhibited C. difficile and neutralized its toxins A and B. These are lab results and do not show an effect in people.

3

Dose response in the capsule trial

In the single hospital capsule trial, two capsules a day (100 billion CFU) were followed by fewer cases than one capsule (15.5% vs 28.2%) and by fewer digestive symptoms. This dose comparison has not been repeated in another published trial.

Clinical trials

1
Bio-K+ CL1285 Capsules, One or Two a Day vs Placebo, in 255 Hospitalized Adults on Antibiotics
PubMed

Single-center, randomized, double-blind, placebo-controlled dose-ranging trial at a Shanghai hospital (NCT00958308, registered after the trial ended); 50 billion CFU capsules of L. acidophilus CL1285 plus L. casei LBC80R, one or two a day, started within 36 hours of the first antibiotic dose and continued for 5 days after the last; primary outcome antibiotic-associated diarrhea; the registry lists Bio-K Plus International, the maker, as lead sponsor with Sprim Advanced Life Sciences as collaborator (Gao et al. 2010, Am J Gastroenterol)

255 adult inpatients receiving antibiotics: 86 on two probiotic capsules, 85 on one probiotic and one placebo capsule, and 84 on two placebo capsules.

Antibiotic-associated diarrhea, the primary outcome, occurred in 15.5% on two capsules, 28.2% on one and 44.1% on placebo. C. difficile-associated diarrhea occurred in 1.2%, 9.4% and 23.8%, and among people who developed diarrhea it lasted 2.8, 4.1 and 6.4 days. Gastrointestinal symptoms were less common on the probiotic. A drug co-treatment result in hospital patients with a formula that named two strains, so it is not counted toward a benefit category here.

2
Bio-K+ CL1285 Fermented Milk vs Placebo in 437 Adults on Antibiotics at Eight Canadian Centers
PubMed

Multicenter, double-blind, randomized, placebo-controlled trial (NCT00328263, which lists Bio-K Plus International as lead sponsor and incidence of antibiotic-associated diarrhea as the primary outcome), 2006 to 2007; 98 g a day of fermented milk with 50 billion CFU of L. acidophilus CL1285 and L. casei (49 g a day for the first 2 days), from within 24 hours of starting antibiotics until 5 days after; placebo prepared by the maker; funded by a grant from BIO K+ International, which paid JSS Medical Research, the authors' employer, to conduct and manage the study (Sampalis et al. 2010, Arch Med Sci)

437 adults prescribed antibiotics for 3 to 14 days in the intent-to-treat analysis (216 probiotic, 221 placebo); more than half were hospitalized.

The paper's primary outcome was the incidence and severity of antibiotic-associated diarrhea; the registry lists incidence alone. Incidence was 21.8% vs 29.4% on placebo, not statistically significant (p = 0.067); the authors state the study had only 40% power for this difference. Mean days with diarrhea were fewer (0.67 vs 1.19, p = 0.040), and an adjusted analysis gave lower odds of diarrhea (odds ratio 0.627, p = 0.037). Treatment was well tolerated.

3
Fermented Milk With L. acidophilus CL1285 and L. casei vs Placebo in 89 Hospitalized Adults
PubMed

Randomized, double-blind, placebo-controlled trial in Montreal; a daily lactobacilli fermented milk with L. acidophilus CL1285 and L. casei, described as widely available in Canada; the abstract does not name the brand, the dose or the funding source (Beausoleil et al. 2007, Can J Gastroenterol)

89 hospitalized adults receiving antibiotics (44 probiotic, 45 placebo).

Antibiotic-associated diarrhea, the main objective, occurred in 15.9% on the fermented milk vs 35.6% on placebo (odds ratio 0.34, 95% CI 0.125 to 0.944; P = 0.05). Median hospital stay was 8 vs 10 days, not significantly different (P = 0.09). The fermented milk was well tolerated.

4
Three-Strain Capsules vs Placebo for 12 Weeks in 113 Adults With IBS: Primary Outcome Not Improved
PubMed

Double-blind, randomized (2:1), placebo-controlled trial at 3 US sites (NCT01545037); two capsules a day of L. acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2 (the abstract gives 50 billion CFU; the registry lists 50 billion CFU per capsule) or placebo; registered primary outcome IBS adequate relief; registry lead sponsor Bio-K Plus International with Sprim Advanced Life Sciences; one author lists Bio-K Plus International and two list Sprim Americas (Preston et al. 2018, Benef Microbes)

113 adults with irritable bowel syndrome of the constipation-predominant, diarrhea-predominant and alternating subtypes.

Adequate relief, the registered primary outcome, and abdominal pain intensity showed no advantage over placebo. Using a 30% improvement threshold, other endpoints such as days of pain, distention, stool frequency and consistency and quality of life favored the probiotic in at least some subgroups, most consistently in diarrhea-predominant IBS and in women. Adverse events occurred in 7 people, none serious.

5
Prevent CDI-55+ Stepped-Wedge Trial in 4 Alberta Hospitals: No Change in the Primary Outcome
PubMed

Stepped-wedge cluster-randomized trial, September 2016 to August 2019, in 4 acute-care hospitals; patients aged 55 and over on therapeutic antibiotics were given 2 capsules a day of Bio-K+ (50 billion CFU of L. acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2), targeted within 12 to 24 hours of the first antibiotic dose and continued 5 days after the last while in hospital; primary outcome hospital-acquired C. difficile infection per 10,000 patient days; funded by Alberta Innovates (PRIHS); one author reported travel support from a Bio-K+ advisory board to present the data (Leal et al. 2024, Infect Control Hosp Epidemiol)

Hospitalized patients aged 55 and over receiving antibiotics at 4 hospitals; adherence ranged from 76.9% to 84.6%.

Hospital-acquired C. difficile infection did not change (incidence rate ratio 0.92, 95% CI 0.68 to 1.23), nor did the test positivity rate (1.05, 0.89 to 1.24). Baseline incidence was low, and discharged patients may not have finished the course. One Lactobacillus bloodstream infection occurred and was a different strain from the probiotic strains.

6
Three-Strain Capsule for 12 Weeks in 30 Adults With Chronic Hand Dermatitis: Single-Group Study
PubMed

Exploratory, single-center, open-label study with no control group; one enteric-coated Bio-K+ 30 Billion capsule a day (L. acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2) after breakfast for 12 weeks alongside standard topical care; the two investigators received research funding from Bio-K Plus International and the third author is its employee (Gulliver et al. 2018, Clin Cosmet Investig Dermatol)

30 adults with mild to severe chronic hand dermatitis; 22 completed the study.

Clinicians noted improvement in 19 of the 22 who finished, and 23% of participants reached clear or almost clear hands at 12 weeks. Itch improved within 2 weeks in 59% of those who had it. One person stopped because of digestive symptoms and one needed systemic therapy. Without a control group, the changes cannot be attributed to the probiotic.

Side effects and drug interactions

Common Potential side effects

In hospital trials the capsules and fermented milk were reported as well tolerated, and gastrointestinal symptoms were less common on the capsules than on placebo.
In a 12-week trial in 113 adults, adverse events occurred in 7 people, all mild or moderate except one case of severe cramping, with no serious events. In a 12-week hand study, 1 of 30 adults stopped because of digestive symptoms, which settled after stopping.
Bloodstream infection has been monitored in hospital use: one Quebec hospital detected no Lactobacillus bacteremia among 44,835 inpatients over 10 years, and in a reported case in a patient given Bio-K+ and a case during the Alberta rollout, molecular testing found the blood isolate was not one of the probiotic strains.
The dairy drinks are made with milk ingredients; the maker also sells vegan drinks and capsules.
NCCIH notes that the risk of harmful effects from probiotics is greater in people with severe illnesses or compromised immune systems, that severe or fatal infections have been reported in premature infants given probiotics, and that some products contain microorganisms other than those on the label.

Important Drug interactions

Antibiotics: in the hospital trials, the probiotic was started within 24 to 36 hours of the first antibiotic dose and continued for 5 days after the last; the registry entry for the 437-adult fermented milk trial says each daily bottle was taken 2 hours before or after the antibiotic dose. No cited study compared different timings against the antibiotic.
Immunosuppressant medicines or other treatments that weaken the immune system: NCCIH notes a greater risk of harmful effects from probiotics in people with compromised immune systems, so ask a doctor first.
No other drug interactions were studied in the trials cited here. Tell your doctor or pharmacist about any supplement you take.

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Frequently asked questions about Bio-K+® (Three-Strain Lactobacillus Probiotic Blend)

What is Bio-K+?

Bio-K+ is a Canadian probiotic, now owned by Kerry, sold as fermented dairy and vegan drinks and as capsules. Most of its products name three strains: L. acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2. Its human trials were mostly in adults taking antibiotics in hospital, and two of the three placebo-controlled trials there were sponsored or funded by the maker.

How much Bio-K+ was used in studies?

Hospital trials used one or two 50 billion CFU capsules a day, with two doing better than one, or 98 g a day of fermented milk with 50 billion CFU. A trial in adults with bowel complaints used two capsules a day for 12 weeks. Retail products range from 12.5 to 80 billion CFU per serving, so check the label.

Can Bio-K+ be taken during a course of antibiotics?

In hospital trials it was started within 24 to 36 hours of the first antibiotic dose and continued for 5 days after the last, and two of three placebo-controlled trials found less antibiotic-associated diarrhea. A hospital-wide rollout in Alberta found no change in hospital-acquired C. difficile infection. Diarrhea that is severe or persistent during or after antibiotics needs a doctor rather than a supplement.

Is today's three-strain formula the one tested in the early trials?

The hospital trials from 2007 to 2010 named L. acidophilus CL1285 and L. casei (LBC80R) without L. rhamnosus CLR2, while papers from 2015 on, including the Alberta rollout and the bowel trial, name all three strains. Maker scientists state the formula has been sold since 1996, but the published papers do not explain the difference.

Is Bio-K+ safe, and does it have side effects?

Trials reported it as well tolerated, with mild digestive complaints in a few people. Lactobacillus bloodstream infections checked in hospital programs were not traced to the probiotic strains. As with other probiotics, people who are seriously ill or have weakened immune systems should ask a doctor first, and the dairy drinks contain milk.

What is Bio-K+ used for?

NutraSmarts does not list Bio-K+ under a health category. What the research covers: In 255 inpatients on antibiotics, one or two 50 billion CFU capsules a day were followed by less antibiotic-associated diarrhea than placebo (28.2% and 15.5% vs 44.1%), and in 89 inpatients the fermented milk gave 15.9% vs 35.6%.

Does Bio-K+ interact with any medications?

Possible interactions include: Antibiotics: in the hospital trials, the probiotic was started within 24 to 36 hours of the first antibiotic dose and continued for 5 days after the last; the registry entry for the 437-adult fermented milk trial says each daily bottle was taken 2 hours before or after the antibi… If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Bio-K+?

NutraSmarts rates the evidence for Bio-K+ as Limited (2 out of 5). It is backed by 6 study summaries and 16 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(16 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. 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. Am J Gastroenterol. 2010;105(7):1636-41. doi: 10.1038/ajg.2010.11.PubMedUsed to support: Single-center, randomized, double-blind, placebo-controlled dose-ranging trial in 255 adult inpatients on antibiotics of Bio-K+ CL1285 capsules (L. acidophilus CL1285 with L. casei LBC80R, 50 billion live organisms per capsule), started within 36 hours of the first antibiotic dose and continued for 5 days after the last: antibiotic-associated diarrhea occurred in 15.5% on two capsules a day, 28.2% on one and 44.1% on placebo, and C. difficile-associated diarrhea in 1.2%, 9.4% and 23.8%. The abstract does not state funding; the registry entry NCT00958308, submitted after the trial ended, lists Bio-K Plus International Inc., the maker, as lead sponsor, with Sprim Advanced Life Sciences as collaborator. A drug co-treatment result in hospital patients.
  2. Sampalis J, Psaradellis E, Rampakakis E. Efficacy of BIO K+ CL1285 in the reduction of antibiotic-associated diarrhea - a placebo controlled double-blind randomized, multi-center study. Arch Med Sci. 2010;6(1):56-64. doi: 10.5114/aoms.2010.13508.PubMedUsed to support: Double-blind, randomized, placebo-controlled trial at eight Canadian centers (NCT00328263) in 437 adults prescribed antibiotics, more than half of them hospitalized: 98 g a day of BIO K+ CL1285 fermented milk (50 billion CFU of L. acidophilus CL1285 and L. casei) from within 24 hours of starting antibiotics until 5 days after. Incidence of antibiotic-associated diarrhea was 21.8% vs 29.4% on placebo (p = 0.067, not significant; the authors state 40% power for this difference), mean days with diarrhea were 0.67 vs 1.19 (p = 0.040), and the adjusted odds ratio was 0.627 (p = 0.037). The registry entry lists Bio-K Plus International as lead sponsor and incidence alone as the primary outcome. The full text states the study was funded by a grant from BIO K+ International, which paid the authors' employer, JSS Medical Research, to conduct and manage it.
  3. Beausoleil M, Fortier N, Guénette S, L'ecuyer A, Savoie M, Franco M, Lachaine J, Weiss K. Effect of a fermented milk combining Lactobacillus acidophilus Cl1285 and Lactobacillus casei in the prevention of antibiotic-associated diarrhea: a randomized, double-blind, placebo-controlled trial. Can J Gastroenterol. 2007;21(11):732-6. doi: 10.1155/2007/720205.PubMedUsed to support: Randomized, double-blind, placebo-controlled trial in 89 hospitalized adults on antibiotics given a daily fermented milk with L. acidophilus CL1285 and L. casei that the authors describe as widely available in Canada: antibiotic-associated diarrhea occurred in 15.9% vs 35.6% on placebo (OR 0.34, 95% CI 0.125 to 0.944; P = 0.05), and median hospital stay was 8 vs 10 days (P = 0.09). The abstract does not name the brand, dose or funding source.
  4. Preston K, Krumian R, Hattner J, de Montigny D, Stewart M, Gaddam S. Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 improve quality-of-life and IBS symptoms: a double-blind, randomised, placebo-controlled study. Benef Microbes. 2018;9(5):697-706. doi: 10.3920/BM2017.0105.PubMedUsed to support: Double-blind, randomized (2:1), placebo-controlled trial in 113 adults with irritable bowel syndrome at 3 sites, two capsules a day of the three-strain blend for 12 weeks. Pain intensity and adequate relief showed no advantage over placebo; other endpoints favored the probiotic in at least some subgroups, most consistently in diarrhea-predominant IBS and women. Adverse events in 7 people, no serious events. The registry entry NCT01545037 names adequate relief as the primary outcome and Bio-K Plus International as lead sponsor; one author lists Bio-K Plus International and two list Sprim Americas.
  5. Leal J, Shen Y, Faris P, Dalton B, Sabuda D, Ocampo W, Bresee L, Chow B, Fletcher JR, Henderson E, Kaufman J, Kim J, Raman M, Kraft S, Lamont NC, Larios O, Missaghi B, Holroyd-Leduc J, Louie T, Conly J. Effectiveness of Bio-K+ for the prevention of Clostridioides difficile infection: Stepped-wedge cluster-randomized controlled trial. Infect Control Hosp Epidemiol. 2024;45(4):443-451. doi: 10.1017/ice.2023.169.PubMedUsed to support: Stepped-wedge cluster-randomized trial (2016 to 2019) in 4 Alberta acute-care hospitals giving patients aged 55 and over on antibiotics 2 capsules a day of Bio-K+ (50 billion CFU of L. acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2). Adjusted analysis found no change in hospital-acquired C. difficile infection (IRR 0.92, 95% CI 0.68 to 1.23) or test positivity (IRR 1.05, 0.89 to 1.24); baseline incidence was low. One Lactobacillus bacteremia occurred and was a different strain from the probiotic. Funded by Alberta Innovates (PRIHS); one author reported travel support from a Bio-K+ advisory board to present the data.
  6. Gulliver WP, Hutton AS, Ship N. Investigating the therapeutic potential of a probiotic in a clinical population with chronic hand dermatitis. Clin Cosmet Investig Dermatol. 2018;11:265-271. doi: 10.2147/CCID.S164748.PubMedUsed to support: Exploratory single-center, open-label study without a control group in 30 adults with chronic hand dermatitis taking one Bio-K+ 30 Billion capsule a day for 12 weeks alongside topical care: 22 completed, 19 of them improved by clinician rating, 23% reached clear or almost clear hands, and itch improved within 2 weeks in 59% of those with itch; one person stopped for digestive symptoms. Two authors received research funding from Bio-K Plus International and the third is its employee.
  7. Maziade PJ, Andriessen JA, Pereira P, Currie B, Goldstein EJ. Impact of adding prophylactic probiotics to a bundle of standard preventative measures for Clostridium difficile infections: enhanced and sustained decrease in the incidence and severity of infection at a community hospital. Curr Med Res Opin. 2013;29(10):1341-7. doi: 10.1185/03007995.2013.833501.PubMedUsed to support: Quasi-experimental, open prospective cohort study at a Quebec community hospital (Pierre-Le Gardeur), not a randomized trial: after a daily 50 to 60 billion CFU dose of the L. acidophilus CL1285 and L. casei LBC80R formula (Bio-K+) was added to standard preventive measures for all patients on antibiotics, C. difficile infection fell from more than 18 to fewer than 5 cases per 1000 admissions, and over 6 years averaged 2.71 vs 8.50 cases per 10,000 patient-days at comparable Quebec hospitals. The authors note the hospital also moved to a new building, which could have contributed.
  8. Maziade PJ, Pereira P, Goldstein EJ. A Decade of Experience in Primary Prevention of Clostridium difficile Infection at a Community Hospital Using the Probiotic Combination Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R, and Lactobacillus rhamnosus CLR2 (Bio-K+). Clin Infect Dis. 2015;60 Suppl 2:S144-7. doi: 10.1093/cid/civ178.PubMedUsed to support: Ten-year observational report from the same Quebec hospital, which from 2004 gave every adult inpatient on antibiotics the probiotic, here named as the three strains, within 12 hours of the prescription: 44,835 inpatients received it, the C. difficile infection rate fell from 18.0 to a mean of 2.3 cases per 10,000 patient-days, and no Lactobacillus bacteremia was detected on blood culture monitoring. No randomized comparison; the authors acknowledge the limits of an observational study.
  9. Trick WE, Sokalski SJ, Johnson S, Bunnell KL, Levato J, Ray MJ, Weinstein RA. Effectiveness of Probiotic for Primary Prevention of Clostridium difficile Infection: A Single-Center Before-and-After Quality Improvement Intervention at a Tertiary-Care Medical Center. Infect Control Hosp Epidemiol. 2018;39(7):765-770. doi: 10.1017/ice.2018.76.PubMedUsed to support: Before-and-after quality improvement study at a 694-bed Chicago-area teaching hospital giving the three-strain probiotic (CL1285, LBC80R, CLR2) to eligible antibiotic recipients: the primary outcome, hospital-onset C. difficile infection incidence, was similar in the baseline and intervention years (6.9 vs 7.0 per 10,000 patient days; P = 0.95), with a decrease only in the last 6 months of the intervention compared with the first 6. Only 26% of eligible patients received the probiotic per protocol. Observational, no concurrent comparator.
  10. Maziade PJ, Ship N, Sniffen JC, Goldstein EJC. Enhanced Clostridioides difficile Infection Prevention With a Pharmacy-Controlled Policy That Adds a 3-Strain Lactobacillus Probiotic Concomitantly to Antibiotic Therapy. Clin Infect Dis. 2021;73(8):1524-1527. doi: 10.1093/cid/ciab414.PubMedUsed to support: Hospital pharmacy policy report: adult antibiotic users were given 1 or 2 capsules a day (by age) of Bio-K+ 50 Billion with the three strains through the antibiotic course and for 5 days after; with 70% of hospitalizations covered, the hospital-wide healthcare-associated C. difficile infection rate was lower than in the preceding observation period (5.2 vs 8.6 per 10,000 patient-days). Observational, no randomized comparator. One author (N. Ship) is a full-time Bio-K Plus International employee.
  11. Auclair J, Frappier M, Millette M. Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R, and Lactobacillus rhamnosus CLR2 (Bio-K+): Characterization, Manufacture, Mechanisms of Action, and Quality Control of a Specific Probiotic Combination for Primary Prevention of Clostridium difficile Infection. Clin Infect Dis. 2015;60 Suppl 2:S135-43. doi: 10.1093/cid/civ179.PubMedUsed to support: Review by three authors from the Bio-K Plus International preclinical research division. States that the three-strain formulation has been marketed in North America since 1996 in fermented beverages and capsules, and that individual strains and finished products showed activity against C. difficile and neutralized toxins A and B in vitro. Laboratory findings, not a human trial.
  12. Aroutcheva A, Auclair J, Frappier M, Millette M, Lolans K, de Montigny D, Carrière S, Sokalski S, Trick WE, Weinstein RA. Importance of Molecular Methods to Determine Whether a Probiotic is the Source of Lactobacillus Bacteremia. Probiotics Antimicrob Proteins. 2016;8(1):31-40. doi: 10.1007/s12602-016-9209-y.PubMedUsed to support: Case report of Lactobacillus bacteremia in a 69-year-old man with severe heart failure on long-term antibiotics who had received Bio-K+ in a hospital program; two blinded laboratories found no genetic relation between his blood isolate and the probiotic strains. Four authors list Bio-K+ Pharma affiliations.
  13. Johnson S, Maziade PJ, McFarland LV, Trick W, Donskey C, Currie B, Low DE, Goldstein EJ. Is primary prevention of Clostridium difficile infection possible with specific probiotics? Int J Infect Dis. 2012;16(11):e786-92. doi: 10.1016/j.ijid.2012.06.005.PubMedUsed to support: Review and meta-analysis of randomized, placebo-controlled trials in adults on antibiotics that measured C. difficile infection: most of 11 trials were seriously underpowered. A meta-analysis of three trials of the L. acidophilus CL1285 and L. casei LBC80R combination, and a combined analysis adding four trials of S. boulardii, showed lower C. difficile rates than placebo (the abstract gives one risk ratio, 0.39, 95% CI 0.19 to 0.79, without saying which analysis it belongs to); the authors called for larger, more rigorous studies. A pooled analysis, not a separate trial.
  14. McFarland LV, Ship N, Auclair J, Millette M. Primary prevention of Clostridium difficile infections with a specific probiotic combining Lactobacillus acidophilus, L. casei, and L. rhamnosus strains: assessing the evidence. J Hosp Infect. 2018;99(4):443-452. doi: 10.1016/j.jhin.2018.04.017.PubMedUsed to support: Narrative review of the evidence for the three-strain Bio-K+ formulation, built partly on communications from the company; three of the four authors list Bio-K Plus International research and development affiliations. It concludes the formula may have a role in preventing healthcare-associated C. difficile infection in patients on antibiotics. A review, not new trial data.
  15. Bio-K Plus International Inc. Bio-K+ probiotic drinks and capsules (product pages) Bio-K+ website (not PubMed-indexed). 2026;Accessed November 2026..SourceUsed to support: Maker website, not PubMed-indexed. Names the three strains L. acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2 and says they are in the majority of its products, while some Bio-K+ products list other strains (L. reuteri LRC, L. fermentum LC40); lists dairy and vegan drinks with a minimum of 50 billion live bacteria per bottle and capsules from 12.5 to 80 billion CFU (for example, DailyCARE+ 50 billion: a minimum of 50 billion CFU per capsule guaranteed until expiration). The footer describes Bio-K+ as a Kerry company. Cited for current strains, forms and counts.
  16. National Center for Complementary and Integrative Health. Probiotics: Usefulness and Safety NCCIH (not PubMed-indexed). 2019;Last updated August 2019; accessed November 2026..SourceUsed to support: US government health information page, not PubMed-indexed. States that the risk of harmful effects from probiotics is greater in people with severe illnesses or compromised immune systems, that severe or fatal infections have been reported in premature infants given probiotics, and that some products contain microorganisms other than those on the label.