Benefits
Upper respiratory symptom duration in healthy adults
In a placebo-controlled trial in 1,104 healthy adults drinking at least 1 billion CFU a day for 42 days, upper respiratory symptoms lasted 6.4 versus 7.3 days on average in the last 3 weeks. This outcome was not in the trial registry; the main outcome, flu vaccine response, did not improve, and symptom incidence and severity did not differ. Chr. Hansen sponsored the trial and five of nine authors worked there.
Antibody response after a seasonal vaccine (marker studies)
In 211 healthy adults, a dairy drink with at least 1 billion CFU a day for 6 weeks gave larger rises in vaccine-specific blood IgG and saliva IgA than placebo, with no change in cytokines. The later 1,104-person trial found no change in any part of the vaccine response. Antibody levels are markers, not illness outcomes.
Perineal wound healing scores after childbirth
In 74 first-time mothers with a perineal incision, one 1.5 billion CFU capsule a day for 14 days gave better wound healing scores, the main outcome, than placebo; pain did not differ. A second paper from the same registration describes about 21 days of use, a different capsule supplier, no funding rather than university funding, and more diarrhea and bloating on the probiotic.
Mood scores in the weeks after childbirth
In 74 women given one 1.5 billion CFU capsule or placebo daily for about 3 weeks after delivery, scores on the Edinburgh postnatal mood questionnaire did not differ between groups at 5, 15 or 21 days. Diarrhea and bloating were reported more often on the probiotic in the first 2 weeks.
Energy intake at the next meal
In a crossover study in 16 healthy men, a breakfast dairy drink with the strain was followed by lower energy intake for the rest of the day than a control drink, though less than with an inulin drink. When 431 was paired with inulin for 21 days, appetite ratings, appetite hormones and body measures did not change.
Mechanism of action
Survival and attachment in lab digestion models
In laboratory tests, the strain survived simulated stomach and intestinal conditions, attached to gut cell layers and matrix proteins, and reduced the attachment of E. coli and Salmonella to gut cells. These are lab results and do not show what happens in people.
Antibody markers after vaccination
In one 211-person trial, vaccine-specific IgG in blood and secretory IgA in saliva rose more than on placebo, while cytokines and innate immune measures did not change. The much larger 1,104-person trial did not confirm a change in vaccine antibodies, and how the strain might shorten symptoms was not measured.
Fat storage in rats (animal work)
In rats fed a high-fat diet for 10 weeks, the strain reduced fat around the testes, liver enzymes and blood triglycerides compared with untreated rats, along with changes in fat-metabolism gene markers. This is animal work and has not been tested in people.
Clinical trials
Randomized, double-blind, placebo-controlled, parallel-group trial at two centers; an acidified milk drink with at least 1x10^9 CFU L. casei 431 or placebo daily for 42 days, with seasonal flu vaccination on day 21; registered ISRCTN08280229 (Jespersen et al. 2015, Am J Clin Nutr)
1,104 healthy adults aged 18 to 60 in Germany and Denmark (553 probiotic, 551 placebo).
The primary outcome, seroprotection 21 days after vaccination, did not differ, and no component of the vaccine immune response changed. Among outcomes the paper lists as other outcomes but the ISRCTN registry does not (it lists only vaccine antibody outcomes), upper respiratory symptoms lasted 6.4 versus 7.3 days on average in the last 3 weeks (P = 0.0059), while incidence and severity did not differ. The registry names Chr. Hansen A/S as sponsor and funder, and five of the nine authors were Chr. Hansen employees.
Randomized, double-blind, placebo-controlled, parallel-group study with separate arms: BB-12 in a capsule or L. casei 431 in a dairy drink, each at a minimum of 1x10^9 CFU once daily, against matching placebos for 6 weeks, with flu vaccination after 2 weeks (Rizzardini et al. 2012, Br J Nutr)
211 healthy adults, 56% women, mean age 33.
In the L. casei 431 arm, rises in vaccine-specific plasma IgG (P = 0.01), IgG1 and IgG3 and in saliva secretory IgA (P = 0.035) were greater than on placebo. Plasma cytokines and innate immune measures did not differ. No illness outcomes were reported. Two of the six authors were Chr. Hansen staff according to the company's 2015 trial; the abstract lists only the first author's affiliation.
Two-phase study; phase 1 was a randomized, double-blind, placebo-controlled crossover of dairy drinks with L. paracasei subsp. paracasei 431 (more than 10^6 CFU/ml), 16 g inulin, both, or maltodextrin control at breakfast on four test days; phase 2 compared 21 days of the 431 plus inulin drink with control (NabizadehAsl et al. 2022, Appetite)
16 healthy men in phase 1; 21 in phase 2 (10 synbiotic, 11 control), in Turkey.
In phase 1, lunch energy intake differed across drinks (p = 0.017), lowest after inulin and next after the probiotic drink, and rest-of-day and 24-hour intake were lower after the inulin and probiotic drinks than control (p < 0.05). In phase 2, hunger and fullness scores, glucose, insulin, PYY, ghrelin, obestatin, adiponectin and body measures did not differ. The abstract does not name a primary outcome; the authors declared no conflict of interest.
Triple-blind randomized placebo-controlled trial registered as IRCT20170506033834N7 and reported in two papers; one 1.5x10^9 CFU L. casei 431 capsule or a maltodextrin placebo daily from the day after birth, for 14 days in the wound paper and about 21 days in the mood paper (Abdollahpour et al. 2023, BMC Complement Med Ther)
74 women who gave birth at a hospital in Tabriz, Iran; the wound paper enrolled first-time mothers with a mediolateral episiotomy.
The wound paper's primary outcome, a REEDA healing score, favored the probiotic (adjusted mean difference -0.50, 95% CI -0.96 to -0.05, P = 0.03), while pain did not differ (P = 0.66) and no side events were reported. The 2025 mood paper found no difference in Edinburgh depression scores (p = 0.71) and reported more diarrhea and bloating on the probiotic in the first 2 weeks. The two papers disagree on several details: 14 versus about 21 days of use, capsules from Tak Gen Zist versus Bio Fermentation, funding from Tabriz University of Medical Sciences versus no funding, and no side events versus more diarrhea and bloating on the probiotic (each 4 of 34, versus 2 and 1 of 35 on placebo, at day 15). Neither reports maker funding.