• LacPro Research
• Science of Probiotics
• LDB B-30892
• Intellectual Properties
• Scientific Collaborators

Genetic characterization from Cornell University’s Laboratory for Molecular Typing, using the RiboPrinter® Microbial Characterization System identified the organism as a unique strain of Lactobacillus bulgaricus. The taxonomic nomenclature recognized by the International Union of Microbiological Societies that applies to the LacPro probiotic is Lactobacillus delbrueckii, ssp. bulgaricus. Further, the strain has been deposited in the Agricultural Research Service Patent Culture Collection and given the NRRL Accession No. B-30892 (LDB), under IDA(4) status (bacterial strains international collection) to allow its availability to the scientific community.

In order to visually observe the cellular morphology of LDB B-30892, the cells were stained with fluorescent dye Acridine Orange (AO) and imaged using a Leica DMLB fluorescent microscope. Figure 1 depicts the cellular morphology.

Lactobacillus are most commonly given “generally recognized as safe” (GRAS) status. There are very few reports in the literature of adverse reactions resulting from the consumption of probiotic bacteria, particularly Lactobacillus and Bifidobacteria. Most lactic acid bacteria are considered safe for human consumption. The company has provided the product to 24 elderly residents with CDI in a total of eight long-term care facilities in both Florida and Indiana and to 15 private practice patients; no adverse effects were reported. One individual has consumed the product daily for three years with no adverse effects reported. Additionally, incubation of 1010CFU/ml LDB did not cause Caco-2 cell death.

The number and the status of the bacteria to be consumed to obtain a beneficial effect are important characteristics of probiotic products. There is no general consensus as to the minimum number of bacteria that need to be consumed to produce a beneficial effect on human metabolism and health. A wide range of numbers of bacteria fed can be found in the scientific literature. Many studies have shown that probiotics must be consumed every day because they do not colonize the gut and are quickly flushed out of the GI tract when consumption is stopped. The company has provided Pro.bio.MAX® for observational studies at a level of at least 30BN units of Lactobacillus delbrueckii spp. bulgaricus B-30892, taken twice daily, and has observed remarkable effectiveness for Clostridium difficile, UC, and Crohn’s at this level. For one patient, the company reduced the dosage to once daily and symptoms recurred. As a result, the company maintains the requirement for 30Bn units per serving, with two servings per day needed for the dietary management of Clostridium difficile.

The company has observed the effectiveness of Pro.bio.MAX® in three primary settings: (1) Fifteen private practice patients, with CDI, UC, and Crohn’s; (2) Eighteen nursing home residents in six long-term care facilities in Florida; and (3) a limited, observational clinical trial conducted by Hancock Regional Hospital. Results observed in all three settings suggest that twice-daily consumption of Pro.bio.MAX®, including at least 30 billion units of LacPro’s proprietary probiotic strain, Lactobacillus delbrueckii spp. bulgaricus B-30892, provides dietary management of Clostridium difficile Infection (CDI) and may also be useful in UC and Crohn’s. The company’s first product is specially formulated for the dietary management of CDI and is based on the evidence observed, including the elimination of diarrhea and documented by reading of Clostridium difficile toxin A and B ELISA negative results in all six private practice patients, in 18 residents in LTC facilities in Florida, and 13 patients in Hancock Regional Hospital. The study at Hancock Regional Hospital also suggests that it may be beneficial in reducing the occurrence of CDI for patients prescribed antibiotic therapies.

The company conducted open label clinical observation studies, between July 2006 and October 2007, in participating institutional care facilities (both long term and acute care) and with patients of a private practice physician. The total number of care facilities included six long-term care facilities in Florida, one regional hospital in Indiana, and two long-term care facilities in Indiana (providing patients to Hancock Regional Hospital). In these observational studies, total 24 patients (n=24) diagnosed with Clostridium difficile Infection (CDI) and total 4 patients (n=4) diagnosed with active Ulcerative Colitis (UC) were orally given a blend ofLactobacillus delbrueckii, ssp. bulgaricus B-30892 (LDB-30892) and Streptococcus thermophilus for 10 days. Another group of six and four patients who received conventional therapies served as controls for CDI and UC, respectively. The study design and the protocols were approved by the institutional review board of the respective facilities. The observations of the study are summarized below: