Probiotic Fails to Prevent Postmenopausal Bone Loss

TOPLINE:

A probiotic with good rationale from animal and human studies known as L reuteri (Limosilactobacillus reuteri 6475) failed in a placebo-controlled clinical trial to prevent early postmenopausal osteoporosis.

METHODOLOGY:

• The study was a randomised, double-blind, placebo-controlled trial of L reuteri in 292 Swedish women aged 50-60 years studied from 2019 to 2022.
• Participants were given capsules containing placebo, high dose (5×10⁹ colony-forming units), or low dose (5×10⁸) L reuteri for 2 years.
• The primary outcome was a relative change in tibia total volumetric bone mineral density (vBMD).
• The secondary outcomes included a relative change in vBMD of the lumbar spine or hip.

TAKEAWAY:

• vBMD of the tibia, spine, and hip declined across all groups, with no significant differences in least-square means between high dose vs placebo groups or low dose vs placebo groups.
• A pre-specified sensitivity analysis designed to check the reliability and robustness of results found a significant interaction between body mass index and treatment effect at 2 years. The authors recommended that this finding be studied further.
• L reuteri was safe and produced no adverse effects.

IN PRACTICE:

The authors concluded that “The findings of this trial suggest that L reuteri 6475 does not affect BMD of the tibia, spine, or hip in early postmenopausal women and should not be recommended to women at this age to prevent bone loss.”

SOURCE:

The corresponding author is Mattias Lorentzon, MD, of Sahlgrenska University Hospital, Molndal, Sweden. The study appeared in JAMA Network Open.

LIMITATIONS:

Limitations included a single-centre study and the inability to generalise findings to other age groups.

DISCLOSURES:

The study was funded by BioGaia AB, the Swedish Research Council, and others. Two of the seven authors reported conflicts of interest.