Summary
Probiotics has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Probiotics to Type 2 Diabetes: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02144948). The largest enrolment is 220 participants (NCT03377946). Registration activity spans 2014 to 2023. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2025 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Type 2 Diabetes Mellitus ranks 767 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 1.6-1.7% at 7 years on standard care (population-level cohorts UK and US).
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 52.5 (trials 17.5, literature 30.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 2 systematic reviews) |
| Agent type | Supplement |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02144948 | Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II 2014 | completed | Phase 3 | 10 |
| NCT04769687 | Symbiotics and Systemic Inflammation in Chronic Kidney Disease 2020 | status unknown | Phase 2 | 62 |
| NCT07072949 | The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin 2023 | completed | Phase 1 | 90 |
| NCT04754464 | Clinical Study on the Effect of a Synbiotic on Body Fat Mass 2020 | completed | Not applicable | 120 |
| NCT03267758 | Effect of Probiotic Supplementation on Endothelial Function II 2018 | completed | Not applicable | 215 |
| NCT02728414 | Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes 2015 | status unknown | Not applicable | 100 |
| NCT05418179 | Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus 2021 | status unknown | Not applicable | 80 |
| NCT03377946 | Effect of Probiotics on Pre-diabetes and Diabetes in China 2017 | status unknown | Not applicable | 220 |
Published literature
- Clinical trial publication Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study)Savytska M, Baka O, Manzhalii E et al. · Frontiers in endocrinology · 2026 · PMID 42158917
- Clinical trial publication Bifidobacterium bifidum G9-1 Intake Improves Gastrointestinal Symptoms in Type 2 Diabetes Mellitus: An Open-Label, Randomized Controlled Trial (Binary STAR Study)Kobayashi G, Hashimoto Y, Matsuyama T et al. · Diabetes, obesity & metabolism · 2026 · PMID 42017290
- Clinical trial publication Multi-strain probiotic enhances metformin tolerance by modulating gut microbiome and bile acid pathways: Insight from multi-omics post-hoc analysis (ProGasMet trial)Kwiendacz H, Cembrowska-Lech D, Skonieczna-Żydecka K et al. · Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2026 · PMID 41985330
- Clinical trial publication Multi-strain probiotic reduces gastrointestinal side effects in women with elevated HOMA-IR index treated with metformin: a 12-week randomised controlled trialRatajczak M, Bilska A, Musialik K et al. · Frontiers in endocrinology · 2026 · PMID 41852479
- Clinical trial publication A multimodal lifestyle intervention program targeting the muscle and gut to improve metabolic health among Indian adults with (pre)diabetes: Design of the GUT-DM randomized trialBhattacharya S, van Helvoort A, Schols AMWJ et al. · Contemporary clinical trials · 2026 · PMID 41554329
- Cochrane review Effects of probiotic supplementation on intestinal microbiota in patients with diabetes/prediabetes: a systematic review and meta-analysis of randomized controlled trialsHong L, Zheng Y, Yang W et al. · The British journal of nutrition · 2026 · PMID 41449894
- Meta-analysis Probiotics, synbiotics and berberine in Type 2 diabetes mellitus: A systematic review, meta-analysis, and molecular dynamics simulation studyShadin M, Bhuia MS, Alfaifi M et al. · PloS one · 2026 · PMID 42213651
- Meta-analysis Effects of Probiotics and Synbiotics Supplementation on Blood Pressure in Adults with Prediabetes and Type 2 Diabetes Mellitus: A Grade-Assessed Systematic Review and Dose-Response Meta-AnalysisSetayesh A, Karimi M, Asbaghi O et al. · Probiotics and antimicrobial proteins · 2026 · PMID 40815364
- Systematic review The role of microbiota derived metabolites in modulating diabetic inflammation: a systematic reviewKarthick V, Thamarai R, Amalraj S et al. · Journal of molecular histology · 2026 · PMID 41843212
- Systematic review Targeting the gut microbiome for type 2 diabetes management: a scoping review of systematic reviews and meta-analysesJiang R, Zheng L, Fang J et al. · Frontiers in endocrinology · 2026 · PMID 41694562
- Cochrane review Intermittent Fasting and Probiotics for Gut Microbiota Modulation in Type 2 Diabetes Mellitus: A Narrative ReviewZhang Z, Wang S, Sun G et al. · Nutrients · 2025 · PMID 41515236
- Cochrane review Effectiveness of probiotic therapy as an adjunct in the management of periodontal disease in type 2 diabetics: A systematic review and meta-analysisYuqi W, Hangying X, Ruyi Y et al. · Diabetes research and clinical practice · 2025 · PMID 40609797
- Cochrane review Probiotic supplementation contributes to glycemic control in adults with type 2 diabetes: A systematic review and network meta-analysisMa D, Zhao P, Gao J et al. · Nutrition research (New York, N.Y.) · 2025 · PMID 40187225
- Cochrane review Probiotics Supplementation for Improving Glucolipid Parameters in Individuals with Prediabetes: A Systematic Review and Meta-Analysis of Randomized TrialsJapar KV, Hariyanto TI, Hamzah DV et al. · Probiotics and antimicrobial proteins · 2025 · PMID 39806201
- Meta-analysis Meta-analytical insight on probiotic metabolites and inflammatory markers in diabetesXie Y, Zheng Y, Jiang F et al. · Frontiers in cellular and infection microbiology · 2025 · PMID 41059033
- Meta-analysis Probiotics and Synbiotics Supplementation Reduce Inflammatory Cytokines in Individuals with Prediabetes and Type 2 Diabetes Mellitus: Findings from a Systematic Review Meta-analysisSetayesh A, Karimi M, Valizadeh F et al. · Advances in nutrition (Bethesda, Md.) · 2025 · PMID 41022286
Mechanism and notes
Recorded mechanism or class: Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Probiotics approved for Type 2 Diabetes?
Probiotics has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Probiotics in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Probiotics to Type 2 Diabetes: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02144948). The largest enrolment is 220 participants (NCT03377946). Registration activity spans 2014 to 2023.
What does the evidence show for Probiotics in Type 2 Diabetes?
Probiotics has both completed registered trials and synthesis-level publications linked to Type 2 Diabetes. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.