Benefits
Bone density in women aged 75 to 80, not in early menopause
In 90 women aged 75 to 80 with low bone density, 10 billion CFU a day of the strain alone, without vitamin D, cut 12-month loss of shin volumetric bone density to 0.83% versus 1.85% with placebo; hip and spine density did not differ significantly. In 239 women aged 50 to 60, neither dose, given with vitamin D, slowed bone loss over 2 years compared with a vitamin D placebo.
Bone turnover markers during a short prednisolone course
In 50 healthy adults aged 18 to 45, 10 billion CFU a day, with vitamin D in both arms, for 2 weeks before and during a 7-day course of prednisolone 25 mg did not change the bone turnover markers CTX, PINP or osteocalcin compared with placebo, and glucose on continuous monitoring did not differ. This drug-exposure test does not show a bone benefit.
Gut barrier and digestive comfort in a 6-week trial
In 65 adults with diarrhea-predominant irritable bowel syndrome, 1 billion CFU a day of the single strain did not change small or large intestinal permeability versus placebo. Symptom scores improved at 3 weeks but not significantly for the single strain, no symptom differed from placebo at 6 weeks, and blood IL-6 tended to fall (p = 0.052).
Testosterone levels in healthy men aged 55 to 65
In a 12-week placebo-controlled trial in 57 men, 1 or 10 billion CFU a day, in capsules with vitamin D that the placebo also contained, did not change testosterone. As a secondary finding, triglycerides fell in the high-dose group (1.54 to 1.20 mmol/L) and differed from placebo. A 10-person open-label study in Japan without a placebo group also saw no notable change in sex hormones.
Two-strain L. reuteri blend with DSM 17938 for digestive comfort
This evidence is for blends of this strain with DSM 17938, not the strain alone. In 140 adults with irritable bowel syndrome, the blend twice daily for 14 weeks with usual care eased symptom scores versus placebo from week 6 and lowered fecal calprotectin. In a separate 6-week trial, the blend's symptom gain at 3 weeks was gone by week 6.
Bone and testosterone findings in animal and lab studies
This is animal and lab work, not human evidence. The strain protected ovariectomized mice from bone loss and lowered markers of bone breakdown, and it slowed formation of bone-resorbing cells in lab dishes. Aging male mice given it in drinking water kept higher testosterone and larger testes; a human trial did not confirm a testosterone effect.
Mechanism of action
Suppression of bone-resorbing osteoclasts
In ovariectomized mice the strain lowered the osteoclast markers Trap5 and RANKL and reduced bone marrow CD4+ T cells, which promote osteoclast formation. In lab cultures, the strain's conditioned supernatant and lactobacillic acid, a fatty acid it makes, blocked osteoclast development and lowered NF-kB and p38 signaling, partly through the GPR120 receptor.
Gut microbiota and inflammatory state in older women
In a secondary analysis of 20 women from the 12-month bone trial, those whose bone density responded best had higher gut bacterial gene richness and a better inflammatory profile than poor responders, and less E. coli enrichment. This compared responders within the probiotic group, not probiotic with placebo.
Shifts in blood metabolites
In a post hoc analysis of the 12-month bone trial, blood metabolite profiles separated the probiotic and placebo groups, and butyrylcarnitine was higher at every time point on the probiotic, which the authors linked to butyrate signaling. No single metabolite stayed significant after correction for multiple testing.
Clinical trials
Randomized, double-blind, placebo-controlled trial of L. reuteri ATCC PTA 6475, 10 billion CFU a day as a powder in stick packs with no vitamin D (placebo was maltodextrin), for 12 months; primary outcome was relative change in tibia total volumetric BMD; funded by BioGaia AB, the Swedish Research Council and Sahlgrenska University Hospital; NCT02422082. (Nilsson et al. 2018, J Intern Med)
90 women aged 75 to 80 with a DXA T-score of -1 or lower at the spine or hip, osteoporosis excluded; 70 completed.
Tibia total volumetric BMD fell 0.83% with L. reuteri versus 1.85% with placebo in the intention-to-treat analysis (mean difference 1.02%, 95% CI 0.02 to 2.03). The secondary bone outcomes, including hip and spine areal BMD, showed similar but smaller effects that were not statistically significant in the intention-to-treat population; trabecular bone volume fraction was significant only in per-protocol and sensitivity analyses. Adverse events did not differ between groups.
Randomized, double-blind, placebo-controlled single-center trial in Sweden of 1 or 10 billion CFU a day (0.5 or 5 billion CFU twice daily) for 2 years, a bone trial whose primary outcome was tibia total volumetric bone mineral density (vBMD); all capsules, placebo included, had 200 IU vitamin D3 (400 IU a day), so the high dose matched the Osfortis daily formula and was compared with vitamin D alone; funded by BioGaia AB, the Swedish Research Council and Sahlgrenska University Hospital, with randomization done by BioGaia; NCT04169789. (Gregori et al. 2024, JAMA Netw Open)
239 women aged 50 to 60 (median 55) in early menopause (80 high dose, 80 low dose, 79 placebo).
The primary outcome was null: tibia total vBMD fell in all groups with no difference from placebo for either dose. Hip and spine vBMD, the turnover markers CTX and PINP, and other predefined outcomes also did not differ. A prespecified analysis found an interaction between body mass index and treatment at 2 years. No treatment-related serious adverse events occurred.
Randomized, double-blind, placebo-controlled proof-of-concept trial of L. reuteri ATCC PTA 6475 on bone turnover markers: 10 billion CFU a day (5 billion CFU twice daily, with 200 IU vitamin D3 per capsule in both arms) for 2 weeks, then open-label prednisolone 25 mg a day for 7 days; funded by the Swedish Research Council, Sahlgrenska grants and BioGaia AB; NCT04767711. (Gregori et al. 2025, JBMR Plus)
50 healthy adults aged 18 to 45 (21 men, 29 women); 46 completed.
The primary outcomes were null: changes in CTX (p = 0.98), PINP (p = 0.43) and osteocalcin (p = 0.21) did not differ between probiotic and placebo. Mean blood glucose on continuous monitoring did not differ either (p = 0.28). The authors call for larger studies to find any smaller effect.
Exploratory randomized placebo-controlled three-arm trial: ATCC PTA 6475 alone (at least 1 billion CFU a day) or with DSM 17938, versus placebo, for 6 weeks; two authors are BioGaia employees and BioGaia financed part of the study; NCT03986476. (König et al. 2024, PLoS One)
65 adults with diarrhea-predominant irritable bowel syndrome.
Small and large intestinal permeability and other gut barrier markers did not change with either product. In the single-strain group, serum IL-6 tended to fall (p = 0.052) and symptoms eased at 3 weeks without reaching significance; only the two-strain group improved significantly at 3 weeks. At 6 weeks no symptom differed from placebo.
Randomized, double-blind, placebo-controlled three-arm trial of 1 or 10 billion CFU a day versus placebo for 12 weeks; every capsule, placebo included, had 5 mcg vitamin D3; BioGaia AB is the registered sponsor and one author is a BioGaia employee; NCT04577625. (Ljunggren et al. 2024, Contemp Clin Trials Commun)
57 healthy men aged 55 to 65 in Sweden.
The primary outcome was null: neither dose changed testosterone. Triglycerides fell in the high-dose group from 1.54 to 1.20 mmol/L and differed from placebo at 6 and 12 weeks (p = 0.013 and 0.014), a secondary finding without correction for multiple tests. Hemoglobin and red cell values dipped in the high-dose group at 6 weeks and returned to baseline by 12 weeks.
Single-arm open-label study without a placebo group: 10 billion live cells of ATCC PTA 6475 a day in two capsules for 12 weeks at Hiroshima University; capsules made by and study funded by BioGaia Japan. (Noda et al. 2026, Biosci Microbiota Food Health)
10 adults aged 50 to 69 in Japan.
Sex hormones did not change notably. Body fat percentage, blood pressure and some inflammation-related values fell from baseline, and fecal Butyricimonas, Holdemania and Odoribacter rose. With no comparison group, these changes cannot be credited to the probiotic.