Benefits
Lactose digestion during a dairy challenge
In two crossover trials of 34 adults each who react to lactose, one dose of about 2.4 trillion CFU of Bi-07 taken with 25 g of lactose lowered breath hydrogen, a sign of undigested lactose, compared with placebo. A lactase enzyme lowered it more in the milk trial. Symptoms did not improve, and the maker funded both trials.
Digestive comfort after a lactose drink
In the same two trials, Bi-07 did not ease abdominal pain, gas or bloating more than placebo, while a lactase enzyme eased pain and gas in the milk trial. In the lactose solution trial, nausea was more frequent and more severe on Bi-07 (odds ratio 4.0), with two cases of vomiting. European regulators found symptom benefit not shown.
Phagocyte activity in adults over 60 (immune marker)
In a maker-funded crossover trial in adults over 60, 1 billion CFU of Bi-07 a day for 3 weeks raised the phagocytic activity of blood monocytes and granulocytes compared with maltodextrin. Carry-over effects meant only the first 3-week period, about nine people per group, could be analyzed, and no infection outcome was measured.
Immune and gut bacteria markers in healthy adults
In a crossover trial in healthy adults aged 25 to 65, 1 billion CFU of Bi-07 a day for 21 days raised fecal B. lactis, lowered salivary IgA and IL-4 release in stimulated blood cultures, and raised IL-6 release, compared with maltodextrin. These are lab markers; the rise in bowel movements in this trial was reported for the fiber XOS, not for Bi-07.
Bowel habits with a Bi-07 enriched cheese
In an open-label trial in 30 women with infrequent, hard bowel movements, 30 g a day of fresh cheese with 100 million CFU of Bi-07 for 30 days improved more bowel symptom criteria than the same cheese without it. Participants knew which cheese they had, the registered main outcome of stool frequency was not reported on its own, and groups were small.
Results from blends with L. acidophilus NCFM
Bi-07 is most often tested with NCFM. In children aged 3 to 5, the two-strain blend was followed by fewer fever and cough episodes than placebo; in adults with bowel symptoms it did not beat placebo on global relief, though bloating was lower at 4 weeks; in active adults it did not lower respiratory illness risk. These results belong to the blend.
Mechanism of action
Lactase activity of the strain (lab work)
In a laboratory model of the upper digestive tract, the maker screened probiotic cultures for lactase, the enzyme that splits milk sugar, and chose Bi-07 for its high activity. The trial dose was then set to match the lactase activity of 4,500 FCC units, the amount used in lactase supplements.
Passage through the gut during intake
In a 21-day trial, 1 billion CFU of Bi-07 a day raised fecal B. lactis counts compared with maltodextrin. In a blend trial during an antibiotic course, people taking NCFM with Bi-07 had higher fecal counts of both strains than on placebo at the end of the antibiotics and at the end of intake.
Genome close to other strains of its subspecies
The complete genome of Bi-07 differs from the type strain of its subspecies by only 40 to 55 single-letter DNA changes and a small change in a CRISPR region. Because strains of this subspecies are so alike, the strain name on the label is the practical way to tell which one a product contains.
Clinical trials
Two randomized, double-blind, placebo- and lactase-controlled, three-way crossover trials, one in Berlin, Germany (NCT03659747, 25 g lactose in fat-free milk) and one in Gieres, France (NCT03814668, registered after enrollment began, 25 g lactose in water); a single dose of freeze-dried Bi-07 (2.40 or 2.34 trillion CFU), lactase (4,662 FCC units) or maltodextrin placebo with each challenge, 1 week apart; primary outcome breath hydrogen incremental area under the curve over 6 hours; supported by IFF, and five authors (Rasinkangas, Forssten, Marttinen, Ibarra, Ouwehand) were IFF employees (Rasinkangas et al. 2022, Am J Clin Nutr)
Adults aged 25 to 60 with self-declared or diagnosed lactose intolerance and a positive lactose breath test; 34 randomized in each trial; 33 analyzed per protocol in the milk trial and 34 in the water trial, where 2 Bi-07 visits were excluded after vomiting.
Breath hydrogen was lower with Bi-07 than placebo in both trials (ratio 0.462, p = 0.016, milk; 0.227, p = 0.001, water). Bi-07 was inferior to lactase in the milk trial and met noninferiority in the water trial. Bi-07 did not ease symptoms versus placebo apart from more nausea; lactase lowered pain and gas in the milk trial. Nausea was more likely on Bi-07 in the water trial (odds ratio 4.0, p = 0.005), with 2 cases of vomiting.
Double-blind, placebo-controlled, randomized four-arm crossover trial at the University of Reading, UK (NCT01586247, registered in 2012 after the trial ended in 2009, with Danisco as collaborator); 1 billion CFU a day of Bi-07 (ATCC SD5220), galacto-oligosaccharides 8 g, both together, or maltodextrin 8 g, in 3-week periods with 4-week washouts; the registered primary outcome was gut microbiota change, with immune function secondary; carry-over effects led the authors to analyze only the first period; DuPont, which makes Bi-07, funded the study, and three authors (Lehtinen, Forssten, Ouwehand) were DuPont employees (Maneerat et al. 2013, J Nutr Sci)
40 healthy adults over 60 randomized; 36 analyzed across four groups.
In first-period data, phagocytic activity of monocytes (p < 0.001) and granulocytes (p = 0.02) was higher with Bi-07 than maltodextrin; the share of cells engaged in phagocytosis, oxidative burst, cytokine responses, plasma chemokines and salivary IgA did not differ. The abstract states that other measures, including the registered gut microbiota outcome, were unchanged. An erratum corrected the figures.
Double-blind, placebo-controlled, randomized factorial crossover trial at the University of Reading, UK (NCT01545219, registered in 2012 after the trial ended in 2010, with Danisco as collaborator); 1 billion CFU a day of Bi-07, xylo-oligosaccharides 8 g, both, or maltodextrin for 21 days each; the registered primary outcome was gut microbiota change, with bowel function, immune function and blood lipids secondary; three authors (Roytio, Forssten, Ouwehand) worked for DuPont Nutrition and Health; the abstract gives no funding statement (Childs et al. 2014, Br J Nutr)
Healthy adults aged 25 to 65; the registry lists 44 enrolled.
Bi-07 raised fecal B. lactis (p = 0.007), lowered stimulated IL-4 in blood cultures (p = 0.035) and salivary IgA (p = 0.040), and raised IL-6 secretion (p = 0.009). More bowel movements, higher fecal bifidobacteria and higher HDL cholesterol were reported for XOS, not Bi-07. No functional outcome was reported for Bi-07 alone.
Randomized, open-label controlled trial in public health units in Guapore, Brazil (NCT01680432, registered in August 2012 after the trial ended in May 2012); 30 g a day of fresh Minas Frescal cheese with 100 million CFU of Bi-07 per serving, or the same cheese without probiotics, for 30 days; the registered primary outcome was bowel movement frequency, while the paper reports Rome III constipation criteria before and after; blinding was not possible; a dairy company donated the cheese; the authors declared no conflict of interest (Favretto et al. 2013, Arq Gastroenterol)
30 adult women aged 20 to 59 meeting Rome III criteria for constipation (15 per group).
The Bi-07 group improved on five of six Rome III criteria and the control group on three, and the authors reported a larger improvement with Bi-07 (p < 0.001). Stool frequency, the registered outcome, was not reported as a separate between-group result in the text. Adverse events were not reported.