Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation
Open accessAbstract
Introduction: A growing body of evidence suggests that specific, naturally occurring gut bacteria are under-represented in the intestinal tracts of subjects with type 2 diabetes (T2D) and that their functions, like gut barrier stability and butyrate production, are important to glucose and insulin homeostasis. The objective of this study was to test the hypothesis that enteral exposure to microbes with these proposed functions can safely improve clinical measures of glycemic control and thereby play a role in the overall dietary management of diabetes. Research design and methods: We evaluated whether a probiotic comprised of these anaerobic bacteria would enhance dietary management by (1) manufacturing two novel probiotic formulations containing three (WBF-010) or five (WBF-011) distinct strains in a Current Good Manufacturing Practice (cGMP) facility, (2) establishing consistent live-cell concentrations, (3) confirming safety at target concentrations dispensed in both animal and human studies and (4) conducting a 12-week parallel, double-blind, placebo-controlled, proof-of-concept study in which subjects previously diagnosed with T2D (n=76) were randomly assigned to a two times a day regimen of placebo, WBF-010 or WBF-011. Results: No safety or tolerability issues were observed. Compared with the placebo group, subjects administered WBF-011 (which contains inulin, Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Bifidobacterium infantis and Anaerobutyricum hallii) significantly improved in the primary outcome, glucose total area under the curve (AUC): −36.1 mg/dL/180 min, p=0.0500 and also improved in secondary outcomes, glycated hemoglobin (A1c): −0.6, glucose incremental-AUC: −28.6 mg/dL/180 min. Conclusions: To our knowledge, this is the first randomized controlled trial to administer four of the five strains to human subjects with T2D. This proof-of-concept study (clinical trial number NCT03893422) shows that the intervention was safe and well tolerated and that supplementation with WBF-011 improves postprandial glucose control. The limited sample size and intersubject variability justifies future studies designed to confirm and expand on these observations.
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The intake of a consortium of butyrate producers may improve metabolic abnormalities and reduce systemic immune activation.
“For example, the intake of a consortium of butyrate producers may improve metabolic abnormalities and reduce systemic immune activation [135].”
From Role of diet and its effects on the gut microbiome in the pathophysiology of mental disorders (2022) · cites this paper as [135]
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- Authors
- Perraudeau, F., McMurdie, P., Bullard, J., Cheng, A., Cutcliffe, C., Deo, A., Eid, J., Gines, J., Iyer, M., Justice, N., Loo, W. T., Nemchek, M., Schicklberger, M., Souza, M., Stoneburner, B., Tyagi, S., & Kolterman, O.
- Affiliations
- Pendulum Therapeutics, Inc, San Francisco, California, USA
- Corresponding author
- Kolterman, Orville
- ORCID
- Venue
- BMJ Open Diabetes Research & Care
- Publisher
- BMJ
- Published
- 2020-07
- Volume
- 8
- Issue
- 1
- Pages
- e001319
- ISSN
- 2052-4897 (ISSN-L)
- PMC
- PMC7368581
- OpenAlex
- W3043255010
- Cited by
- 186
- References
- 48
- Citations by year
- 2026: 26 · 2025: 41 · 2024: 43 · 2023: 27 · 2022: 29 · 2021: 18 · 2020: 2
- FWCI
- 12.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMJ Open Diabetes Research & Care (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- type 2 diabetes, probiotics, postprandial glucose control, anaerobic gut bacteria, probiotic formulation, HbA1c, butyrate production, dietary management of diabetes
- MeSH terms
- Eubacteriales, Blood Glucose, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Probiotics
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