The Beneficial Effects of a Multispecies Probiotic Supplement on Glycaemic Control and Metabolic Profile in Adults with Type 1 Diabetes: A Randomised, Double-Blinded, Placebo-Controlled Pilot-Study

Abstract

Objective In this pilot-study, the effects of a multispecies probiotic supplement on glycaemic control and metabolic parameters in adults with type 1 diabetes (T1DM) were explored. Material and Methods A total of 50 T1DM patients were enrolled and randomly placed into a group receiving capsules containing multi-probiotic strains ( Bifidobacterium longum , Lactobacterium bulagricumi , Streptococcus thermophilus ) and insulin (probiotics group, n = 27) or a group receiving a placebo and insulin (placebo group, n = 23). All patients underwent continuous glucose monitoring at baseline and 12 weeks after intervention. The primary outcomes were determined by comparing factors such as changes in fasting blood glucose (FBG) and haemoglobin A1c (HbA1c) between the groups. Results Probiotic supplementation significantly reduced FBG (−1.0 ± 4.7 vs 1.8 ± 4.7 mmol/L, p = 0.048), 30 min postprandial glucose (−0.5 ± 4.6 vs 1.9 ± 3.3 mmol/L, p = 0.0495), and low-density lipoprotein cholesterol (−0.07 ± 0.45 vs 0.32 ± 0.78 mmol/L, p = 0.0413), compared with the placebo. Although not statistically significant, probiotic supplementation also lowered HbA1c levels by 0.49% (−5.33 mmol/mol, p = 0.310). Besides, no significant difference was observed in the continuous glucose monitoring (CGM) parameters between the two groups. Further subgroup analysis revealed a significant reduction in mean sensor glucose (MSG; −0.75 (−2.11, 0.48) mmol/L vs 1.51 (−0.37, 2.74) mmol/L, p = 0.010) and time above range (TAR; −5.47 (−20.1, 3.04)% vs 18.9 (−1.11, 35.6)%, p = 0.006), as well as an greater improvement in the time in range (TIR; 9.32 (−4.84, 16.6)% vs −19.9 (−31.4, 0.69)%, p = 0.005) in male patients than female patients in the probiotics group. Conclusion Multispecies probiotics exerted beneficial effects on fasting and postprandial glucose and lipid profiles in adult T1DM patients, especially for male patients and those with higher baseline FBG levels.

The Effect of Microbiome-Modulating Agents (MMAs) on Type 1 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…The effect of MMAs on FCP was reported by five studies with seven subgroups ( n = 336) [ 15 , 29 , 33 , 35 , 37 ], and the reports indicated a significant improvement (SMD = 0.99, 95% CI [0.17, 1.81], p = 0.02) ( Figure 5 ). Sensitivity analysis was performed due to high heterogeneity ( I 2 = 90%, p = 0.01, Tau 2 = 1.00).…”

“…Regarding interventions, one study used a prebiotic (inulin) [ 13 ], two studies used a postbiotic (sodium butyrate) [ 30 , 31 ], one study used a single-strain probiotic ( Lactobacillus rhamnosus GG) [ 32 ], and six used multistrain probiotic or synbiotic supplements [ 29 , 33 , 34 , 35 , 36 , 37 ]. To maximize inclusivity, eligibility criteria did not impose restrictions based on age or the duration of T1D.…”

“…Mean participant age ranged from 5.5 to 56 years, and T1D duration ranged from 1.5 to 30 years. Six studies implemented MMA supplementation for 3 months [ 30 , 31 , 32 , 33 , 35 ], with one study using less than 3 months [ 34 ] and three studies exceeding 3 months [ 29 , 34 , 37 ]. Beyond post-intervention assessments, three studies also measured outcomes 3 months and 6 months after intervention completion [ 15 , 34 , 37 ].…”

“…Heterogeneity rates in both subgroups were low (8% for more than 3 months, and 0% for equal or less than 3 months), and the test for subgroup differences indicated a statistically significant effect (Chi 2 = 22.74, df = 1 (p < 0.001), I 2 = 95.6%). [35,36]. The Shannon index was reported in two studies (n = 68) [15,31], and there was no difference (SMD = −0.66; 95% CI [−1.62, 0.30], p = 0.18).…”

“…Mean participant age ranged from 5.5 to 56 years, and T1D duration ranged from 1.5 to 30 years. Six studies implemented MMA supplementation for 3 months [30][31][32][33]35], with one study using less than 3 months [34] and three studies exceeding 3 months [29,34,37].…”