Heat-inactivated Lacticaseibacillus paracasei fermented milk (postbiotic) did not outperform placebo for functional constipation
A 4-week double-blind RCT found no significant between-group difference in any primary or secondary clinical outcome for this postbiotic versus placebo.
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What the study showed
Both groups improved over time within group, but no significant differences were observed between groups in spontaneous bowel movement frequency (MD = −0.14; p = 0.683), complete spontaneous bowel movements (MD = 0.27; p = 0.543), or whole-gut transit time (MD = −1.55 h; p = 0.614). Dropout was 4% and adherence exceeded 80% in both arms.
How it was done
Randomized, double-blind, placebo-controlled trial enrolling 100 adults aged 45–75 with Rome IV-defined functional constipation, treated for 4 weeks. Per-protocol analysis (n = 96) was primary; intention-to-treat analysis covered primary and key secondary outcomes.
Risk of bias
Four weeks may be insufficient to capture postbiotic effects; the abstract does not detail placebo composition or serum biomarker results, precluding full assessment. Substantial within-group improvement in both arms suggests a prominent placebo response.
What this study does NOT prove
This study does not prove that Lacticaseibacillus paracasei postbiotics are universally ineffective; it only shows that this specific product, at this dose and duration, did not surpass placebo.
In clinical practice
This study provides no basis for recommending this specific postbiotic for functional constipation. Clinicians should note that within-group improvements likely reflect placebo or attention effects rather than active treatment.
Limitations
Four weeks may be insufficient to capture postbiotic effects; the abstract does not detail placebo composition or serum biomarker results, precluding full assessment. Substantial within-group improvement in both arms suggests a prominent placebo response.
Technical appendix
Version history
- 1.0 · 2026-07-19 — Auto-generated under Evidence Standard v1.0
Paid access: structured summary from public metadata; consult the original study at the source.