Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 32675291 · doi:10.1136/bmjdrc-2020-001319
What was done
In a 12-week, multicenter, double-blind, placebo-controlled proof-of-concept trial, 76 participants diagnosed with type 2 diabetes were randomly assigned to receive a twice-daily regimen of placebo, a 3-strain probiotic formulation (WBF-010), or a 5-strain formulation with inulin (WBF-011, containing Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Bifidobacterium infantis, and Anaerobutyricum hallii). Safety, tolerability, and glycemic parameters were assessed.
What was found
No safety or tolerability issues were observed. Compared with placebo, participants receiving WBF-011 showed a statistically significant improvement in the primary outcome, glucose total area under the curve (AUC: -36.1 mg/dL/180 min, p=0.0500). WBF-011 also showed improvements in secondary outcomes: glycated hemoglobin (A1c: -0.6) and glucose incremental-AUC (-28.6 mg/dL/180 min). Numerical findings for the WBF-010 arm were not reported in the abstract.
Why it matters
This provides initial proof-of-concept evidence that supplementing specific anaerobic gut bacterial strains can safely improve postprandial glycemic control and HbA1c in type 2 diabetes.
Limits
The sample size was small (76 participants divided across three arms) and the trial duration was short (12 weeks). The primary outcome achieved only borderline statistical significance (p=0.0500), and confidence intervals and secondary outcome p-values were not provided. Outcomes for the 3-strain formulation (WBF-010) were not reported in the abstract.
Cited by
- context Akkermansia muciniphila requires butyrate to function, which is why probiotic formulations pair it with Clostridium butyricum.