Gut health and microbiome modulation by the heat-killed postbiotic beLP1® in adults with excess weight: a randomized, placebo-controlled trial
Abstract
Overweight is linked to gut microbiota dysbiosis and gastrointestinal (GI) symptoms that impair quality of life.
This 84-day randomized, double-blind, placebo-controlled study evaluated the gut-health effects of heat-killed
Lactiplantibacillus plantarum
(beLP1
®
) in otherwise healthy adults (aged 18–45 years) within the BMI range of 25–35 kg/m
2
and a ≥3-month history of mild-to-moderate GI discomfort, confirmed by Gastrointestinal Symptom Rating Scale (GSRS). In this trail 140 adults were allocated in a 1:1 ratio to receive either daily beLP1
®
(>30 billion cells) (
n
= 70) or placebo (
n
= 70). A total of 103 participants completed the study without protocol deviations and were included in the primary per-protocol (PP) analysis (beLP1
®
:
n
= 49; Placebo:
n
= 54). This predefined analysis directly compares the beLP1
®
and placebo arms using analysis of covariance (ANCOVA), supplemented by two independent-sample Student’s
t
-tests. The primary endpoint was change in gastrointestinal symptoms via the GSRS, secondary endpoints included the Perceived Stress Scale (PSS), the Digestion-associated Quality of Life Questionnaire (DQLQ), Tumor Necrosis Factor-alpha (TNF-α), lipid parameters, Dual-Energy X-ray Absorptiometry (DEXA), and gut microbiome diversity by metagenomic Next-Generation Sequencing (NGS).
Compared to placebo, beLP1
®
significantly reduced total Gastrointestinal Symptom Rating Scale (GSRS) scores at Day 42 (
p
= 0.0215) and Day 84 (
p
= 0.0394), with prominent…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 140 participants or records.
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