Table 3.
Summary of clinical trials evaluating the effect of probiotic supplementation alone in individuals with T2DM.
| Sample Size | Design | Duration | Intervention | Metabolic Outcomes | Microbiota Modifications | Functional Modifications | Study |
|---|---|---|---|---|---|---|---|
| Placebo (18) Intervention (16) |
Single-blind clinical trial | 6 weeks | Probiotic: 3000mg/day of L. acidophilus, L. bulgaricus, L. bifidum, and L. casei | Probiotic: n.s. | - | - | [77] |
| Placebo (53) Intervention (48) |
Randomized, double-blind, parallel-group, controlled clinical trial | 12 weeks | Probiotic: 3 × 1010 CFU/day of L. acidophilus, L. casei, L. lactis, B. bifidum, B. longum, and B. infantis | Probiotic: ↓ HbA1C, FI, HOMA-IR |
Probiotic: ↑ Bifidobacterium spp., former-Lactobacillus spp. |
- | [78] |
| Placebo (39) Intervention (39) |
Randomized, single-centre, double-blind, placebo-controlled | 12 weeks | Probiotic: 1010 CFU/day of B. bifidum W23, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, L. lactis W19, and L. lactis W58 |
Probiotic: ↓ HOMA-IR, FBG, Insulin, C-peptide, TG, LDL-c, WHR |
- | - | [79] |
| Placebo (15) Intervention (29) |
Randomized, double-blind, placebo-controlled trial |
12 weeks | Probiotic: L.
reuteri DSM 17938 LD: 108 CFU/day HD: 1010 CFU/day |
Probiotic: HD: ↑ ISI, DCA LD: ↑ unconjugated bile acids |
Probiotic: ↑ L. reuteri |
- | [80] |
| Placebo (22) Intervention (46) |
Randomized, double-blind, placebo-controlled trial |
9 months (6 month intervention) |
Group 1: 4 × 109 CFU/day of probiotic L. reuteri ADR-1 Group 2: 2 × 1010 CFU/day heat-killed L. reuteri ADR-3 |
Group 1: ↓ HbA1C, TC Group 2: ↓ SBP, IL-1β |
Group 1: ↑ L. reuteri Group 2: ↑ Bifidobacterium |
- | [81] |
| Placebo (22) Intervention (31) |
Randomized, double-blind, single-centre, clinical trial |
8 weeks | Probiotic: 1 sachet (10g)/day of 14 probiotic strains of former-Lactobacillus + Lactococcus (6 × 1010 CFU/g), Bifidobacterium (1 × 1010/g), Propionibacterium (3 × 1010/g), Acetobacter (1 × 106/g) genera | Probiotic: ↓ HOMA-IR, TNF- α, IL-1β, WC |
- | - | [82] |
| Placebo (30) Intervention (31) |
Randomized, single-centre, double-blind, placebo-controlled clinical trial | 6 months | Probiotic: 1010 CFU/day of B. bifidum W23, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, L. lactis W19 and L. lactis W58 | Probiotic: ↓ HOMA-IR, FBG, Insulin, C-peptide, TG, TC, TC/HDL, CRP, TNF-α, IL-6, resistin, endotoxin ↑ adiponectin |
- | - | [83] |
| Placebo (20) Intervention (20) |
Randomized, parallel-group, placebo-controlled trial |
8 weeks | Probiotic: 108 CFU/day of L. casei | Probiotic: ↓ FBG, HOMA-IR, Insulin, fetuin-A, weight, BMI, WC ↑ SIRT1 |
- | - | [84] |
| Placebo (30) Intervention (30) |
Randomized, double-blind, single-centre, placebo-controlled pilot trial |
12 weeks | Probiotic: 2 × 1011 CFU/day of L. plantarum Lp-115, L. bulgaricus Lb-64, L. gasseri Lg-36, B. breve Bb-03, B. animalis sbsp. lactis Bi-07, B. bifidum Bb-06, S. thermophilus St-21, and S. boulardii DBVPG 6763 | Probiotic: ↑ plasma butyrate Subgroup (metformin): ↓ FBG, HbA1C, insulin resistance, and zonulin ↑ plasma butyrate |
Probiotic: n.s. beta diversity ↓ P. copri, Flavonifractor plautii ↑ B. breve, B. caccae, Bacteroidales bacterium ph8, A. muciniphila, C. hathewayi Subgroup (metformin): ↓ Bactoides uniformis ↑ B. breve, B. caccae, Anaerotruncus colihominis |
Subgroup (metformin): pyruvate fermentation to butanoate, and Bifidobacterium shunt pathways | [85] |
Abbreviations: N.s.: not significant; HbA1C: hemoglobin A1C; HOMA-IR: Homeostatic Model Assessment for Insulin Resistance; FBG: fasting blood glucose; IR: insulin resistance; TG: triglycerides; WHR: waist-to-hip ratio; LD: low dose; HD: high dose: ISI: insulin sensitivity index; DCA: deoxycholic acid; SBP: systolic blood pressure; IL-1β: interleukin 1 beta; IL-6: interleukin 6; TNF-α: tumor necrosis factor alpha; WC: waist circunference; TC: total cholesterol; LDL-c: low-density lipoprotein cholesterol; HDL: high density lipoprotein; CRP: C-reactive protein; BMI: body mass index; SIRT1: sirtuin 1. Bacteria: A. muciniphila: Akkermansia muciniphila; B. caccae: Bacteroides caccae; B. bifidum: Bifidobacterium bifidum; B. breve: Bifidobacterium breve; B. longum: Bifidobacterium longum; B. infantis: Bifidobacterium infantis; C. hathewayi: Clostridium hathewayi; L. casei: Lacticaseibacillus casei; L. plantarum: Lactiplantibacillus plantarum; L. acidophilus: Lactobacillus acidophilus; L. bifidum: Lactobacillus bifidum; L. bulgaricus: Lactobacillus bulgaricus; L. gasseri: Lactobacillus gasseri; L. lactis: Lactococcus lactis; L. brevis: Levilactobacillus brevis; L. salivarius: Ligilactobacillus salivarius; L. reuteri: Limosilactobacillus reuteri; P. copri: Prevotella copri; S. boulardii: Saccharomyces boulardii; S. thermophilus: Streptococcus thermophilus.