Benefits
Quality-of-life scores with year-round nasal symptoms
In two 30-day placebo-controlled trials in Taiwan, 80 people drinking fermented milk with LP-33 and 90 people taking live or heat-killed LP-33 capsules reported larger drops in how often and how much nasal symptoms bothered them than with placebo. Neither was registered, and the abstracts do not report ages, funding, a named primary outcome or symptom scores.
Nasal quality-of-life scores during grass pollen season
In 425 adults with grass pollen allergy, capsules of at least 2x10^9 CFU LP-33 a day improved a rhinitis quality-of-life score more than placebo at week 5, the main outcome, while the total nasal and eye symptom score did not differ. Every participant also took the antihistamine loratadine, so this trial does not test LP-33 on its own. Merck and Chr. Hansen staff were among the authors.
Sneezing scores in children over 3 months
In 122 children with year-round nasal allergy given one of three doses of live GM-080 or placebo for 3 months, the total nasal symptom score, the main outcome, did not differ (p = 0.070). Sneezing scores and the investigators' global assessment differed only in tests across all four groups. GenMont co-funded the study and supplied the probiotic.
Skin scores in infants using a steroid cream (heat-treated cells)
In infants aged 4 to 30 months with eczema-type skin symptoms, a daily heat-treated GM-080 supplement for 16 weeks alongside a steroid cream did not change skin scores, itch, quality of life or steroid use compared with placebo. Total IgE rose more in the supplement group. Nestlé ran the trial.
Mechanism of action
Th1 cytokine signals in mouse cells
Among 23 L. paracasei strains tested on mouse spleen cells, GM-080 raised the Th1 signals IFN-gamma and IL-12 the most. In the children's trial, serum IFN-gamma rose in the higher-dose groups without reaching significance and total IgE did not change significantly, so this effect has not been shown in people.
Airway inflammation in a mouse model
In mice sensitized to ovalbumin, oral GM-080 for about 8 weeks reduced airway reactivity, white blood cells and the signals eotaxin and IL-5 in lung fluid. This is animal work and does not show the same effect in people.
Genome features and safety screening
Whole-genome sequencing found DNA motifs in GM-080 that raised IL-12 in mouse cells, genes for making exopolysaccharides, no plasmids, and no known antibiotic resistance or virulence genes; tested antibiotics stopped its growth below European cutoffs. These are laboratory findings.
Clinical trials
Double-blind, randomized, placebo-controlled, multicenter trial run by general practitioners; one capsule with at least 2x10^9 CFU LP-33 or placebo daily, with loratadine for all participants for 5 weeks (the registry lists 7 weeks of product); registered NCT01096615 before it started (Costa et al. 2014, Eur J Clin Nutr).
425 adults aged 18 to 60 with persistent nasal allergy, sensitized to grass pollen and symptomatic during the pollen season, with impaired quality of life.
The primary outcome, the Rhinitis Quality of Life Questionnaire global score at week 5, improved more than with placebo (difference -0.286, 95% CI -0.536 to -0.035, P = 0.0255). The total symptom score did not differ (P = 0.1288), and eye symptoms on the questionnaire improved more (P = 0.0029). The registry names Merck Médication Familiale as sponsor and Novonesis as collaborator; one author was from Chr. Hansen, two from Merck and three from the contract research firm Biofortis. The trial calls the strain LP-33; GenMont-linked researchers identify GM-080 as LP-33.
Randomized, double-blind, placebo-controlled trial; fermented milk with LP-33 (2x10^9 CFU per bottle) or the same milk without it for 30 days; quality of life measured with a modified pediatric rhinoconjunctivitis questionnaire (Wang et al. 2004, Pediatr Allergy Immunol).
80 patients with perennial allergic rhinitis in Taiwan (60 LP-33, 20 placebo); the abstract does not give their ages.
Overall quality-of-life scores fell more with LP-33 than with placebo for symptom frequency (p = 0.037) and level of bother (p = 0.022). No severe adverse effects such as fever, abdominal pain or diarrhea were reported. The abstract does not state the funder; the GenMont registry for a later trial describes a 30-day LP-33 fermented-milk trial as testing the original form of eN-Lac®, though the p values it quotes (0.044 and 0.036) differ from this paper's.
Randomized, double-blind, placebo-controlled, three-arm trial; two capsules a day of live or heat-killed LP-33 (5x10^9 CFU per capsule) or placebo for 30 days (Peng et al. 2005, Pediatr Allergy Immunol).
90 patients with perennial allergic rhinitis caused by house dust mite; the abstract does not give their ages.
Overall quality-of-life scores improved more with both live and heat-killed LP-33 than with placebo for frequency (p < 0.0001) and level of bother (p = 0.004); the abstract does not say whether these p values compare each form with placebo or all three groups, and the authors judged the heat-killed form not inferior to the live one. No obvious side effects were reported. The abstract does not state a primary outcome or the funder. The paper calls the strain LP33 and comes from the same hospital department and senior author as the fermented-milk trial; no source read ties it to GenMont directly.
Double-blind, randomized, placebo-controlled trial of three doses of live GM-080 (2x10^8, 2x10^9 or 1x10^10 CFU/day) or placebo for 3 months, run in 2006 and 2007 and reported with a mouse airway study; registered ISRCTN14829274 in 2022, after the trial ended (Lin et al. 2023, Cells).
137 children aged 5 to 16 with perennial allergic rhinitis were randomized and 122 analyzed (28, 31, 31 and 32 per group).
The primary outcome, change in nasal allergy severity scored by the total nasal symptom score, did not differ between groups (p = 0.070 across the four groups). Sneezing scores (p = 0.041) and Investigator Global Assessment scores at 3 months (p = 0.049) differed only in tests across all four groups, with no dose trend. Total IgE did not change significantly, and serum IFN-gamma rose without reaching significance. Funded by a government grant and by GenMont Biotech, which supplied the probiotic; two authors (Tsai WH, Chou CH) are GenMont employees, and GenMont is the registry sponsor.
Randomized, double-blind, placebo-controlled, multicenter trial in Taiwan; heat-treated GM-080 or maltodextrin placebo once daily for 16 weeks, added to fluticasone propionate cream; the abstract does not give the dose; registered NCT02103972 by Société des Produits Nestlé (Yan et al. 2019, Skin Pharmacol Physiol).
Infants aged 4 to 30 months with atopic dermatitis; the registry lists 126 enrolled.
The primary outcome, SCORAD, and itching, objective SCORAD and quality of life fell over time in both groups with no difference between them; skin water loss and CCL17 did not differ. Total IgE rose in both groups, more with the supplement (p = 0.038). There was no steroid-sparing effect. Four authors were Nestlé Research staff.
Randomized trial at one hospital in Karachi; one chewable tablet with 2x10^9 CFU LP-33 a day or cetirizine for 6 weeks; the methods call it placebo-controlled, but the comparison group received cetirizine (Ahmed et al. 2019, Pak J Med Sci).
264 children aged 6 to 60 months with perennial allergic rhinitis symptoms were randomized and 212 analyzed.
More than 95% of children in both groups improved and the groups did not differ (P > 0.05). With no placebo group, this design cannot show whether LP-33 itself had an effect. Funded by High-Q Pharmaceuticals; the authors declared no competing interests.