Heat-killed postbiotic beLP1® reduces gastrointestinal symptoms in adults with excess weight: randomized controlled trial
beLP1® produced a statistically significant, favorable reduction in total GSRS scores compared to placebo at days 42 and 84, though absolute effect sizes were not reported in the available text.
| Population | Healthy adults, 18–45 years, BMI 25–35 kg/m², with ≥3-month history of mild-to-moderate GI discomfort confirmed by GSRS |
|---|---|
| Intervention | beLP1® (heat-killed Lactiplantibacillus plantarum, >30 billion cells/day) for 84 days |
| Comparator | Identical oral placebo for 84 days |
| Outcome | Total GSRS score (day 84); Total GSRS score (day 42); Perceived stress (PSS); Digestion-related quality of life (DQLQ); Serum TNF-α; Lipid profile; Body composition (DEXA) |
Summary of findings
| Outcome | Effect | 95% CI | Certainty | Clinical relevance | Notes |
|---|---|---|---|---|---|
| Total GSRS score (day 84) | p=0.0394; absolute MD and 95% CI not reported | — | Low | — | 1 studies |
| Total GSRS score (day 42) | p=0.0215; absolute MD and 95% CI not reported | — | Low | — | 1 studies |
| Perceived stress (PSS) | p=0.0004; absolute MD and 95% CI not reported | — | Low | — | 1 studies |
| Digestion-related quality of life (DQLQ) | p=0.0008; absolute MD and 95% CI not reported | — | Low | — | 1 studies |
| Serum TNF-α | p not significant; values not reported | — | Low | — | 1 studies |
| Lipid profile | p not significant; values not reported | — | Low | — | 1 studies |
| Body composition (DEXA) | p not significant; values not reported | — | Low | — | 1 studies |
Context
Adults with overweight or class I obesity frequently present with gut microbiota dysbiosis and functional gastrointestinal symptoms that impair quality of life. Heat-killed bacterial postbiotics offer a stable alternative to viable probiotics with a potentially distinct safety profile. This study is the first published RCT evaluating the beLP1® postbiotic (heat-killed L. plantarum) specifically in this population.
What the study showed
beLP1® significantly reduced total GSRS scores vs. placebo at day 42 (p=0.0215) and day 84 (p=0.0394), with improvements in abdominal pain (p=0.0205) and dyspeptic syndrome (p=0.0303) domains. Perceived stress (PSS) decreased (p=0.0004) and digestion-related quality of life (DQLQ) improved (p=0.0008) in the active group. Metagenomic analysis indicated enrichment of SCFA-producing bacteria and reduction of opportunistic pathogens. TNF-α, lipid profile, and DEXA body composition metrics did not differ significantly between groups.
How it was done
Double-blind, placebo-controlled RCT, 84 days, 1:1 randomization (n=140; beLP1®: n=70, placebo: n=70). Primary per-protocol (PP) analysis included 103 participants without protocol deviations (beLP1®: n=49; placebo: n=54). Statistical analysis by ANCOVA adjusted for baseline values, supplemented by independent-sample t-tests.
Effect magnitude
Absolute differences in GSRS scores and 95% confidence intervals were not reported in the available text, precluding full assessment of clinical magnitude. Primary endpoint p-values range from 0.02 to 0.04, indicating borderline statistical significance.
Risk of bias
High dropout/exclusion rate due to protocol deviations: 37 of 140 participants (26.4%) excluded from PP analysis, potentially introducing selection bias and reducing internal validity. RoB 2 tool not explicitly mentioned. Absence of reported intention-to-treat (ITT) analysis. Final sample size (n=103 PP) is modest for multiple secondary endpoints. 84-day duration does not permit assessment of long-term effects.
What this study does NOT prove
This study does not prove causality between microbiome modulation and symptomatic improvement, nor generalizability to individuals outside the 18–45 age range or with BMI >35 kg/m². It does not demonstrate effects on body weight, systemic inflammation, or metabolic parameters.
In clinical practice
Clinicians may consider beLP1® as an adjunct option for management of mild-to-moderate functional gastrointestinal symptoms in adults with overweight or class I obesity. This study provides no evidence for indications in weight management, systemic inflammation, or dyslipidemia. Decisions should account for the modest sample size and absence of published absolute effect sizes.
Limitations
High dropout/exclusion rate due to protocol deviations: 37 of 140 participants (26.4%) excluded from PP analysis, potentially introducing selection bias and reducing internal validity. RoB 2 tool not explicitly mentioned. Absence of reported intention-to-treat (ITT) analysis. Final sample size (n=103 PP) is modest for multiple secondary endpoints. 84-day duration does not permit assessment of long-term effects.
What is still missing
RCTs with pre-specified ITT analysis, larger samples, and follow-up >6 months are needed to confirm durability of effects. Studies in other populations (BMI >35, elderly, established GI pathologies) are absent.
Technical appendix
Version history
- 1.0 · 2026-10-05 — Auto-generated under Evidence Standard v1.0