Abstract
BackgroundThe beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively. However, its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood. To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals.MethodsA randomized, double-blind, parallel-group, controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30-70 years old in a teaching hospital in Kuala Lumpur, Malaysia. Subjects were randomly assigned to receive microbial cell preparation (N = 68) or a placebo (N = 68) for 12 weeks. The outcomes measured at baseline, week 6, and week 12 and included changes in renal profile (Sodium, Potassium, Urea, Creatinine, Glomerular Filtration Rate), and liver function tests (Albumin, Total Protein, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase). Intention to treat (ITT) analysis was performed on all the recruited subjects, while per protocol (PP) analysis was conducted on those who completed the trial with good compliance.ResultThe urea levels significantly declined in the probiotic group. Serum urea levels reduced from 4.26 mmol/L to 4.04 mmol/L in Probiotic Group while it increased in Placebo Group from 4.03 mmol/L to 4.24 mmol/L. These changes were significant between groups in ITT analysis (p = 0.018). Other parameters did not change significantly between groups.Conclusion12 weeks supplementation with daily dosage of 6 × 1010 Colony Forming Units of multi-strain microbial cell preparation significantly improved urea levels.Trial registration(Clinical trials: #NCT01752803)Electronic supplementary materialThe online version of this article (doi:10.1186/s12906-015-0952-5) contains supplementary material, which is available to authorized users.
Highlights
The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively
Type 2 diabetic individuals with stabilized dose of medication, age 30 to 70, with Glycated Hemoglobin A1c (HbA1c) between 6 and 12 %, Fasting Blood Glucose (FBG)
The two groups were comparable at baseline in terms of age, BMI, dietary intake, physical activity level (Table 1), treatment modalities and comorbidities (Table 2), renal profile and liver function tests (Table 1)
Summary
The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively. Proof for the above purport is that, gut microbiota is altered in patients with Chronic Kidney Disease (CKD) [3] and non-alcoholic steatohepatitis [4] as compared with healthy subjects. Different small-scaled clinical trials in hemodialysis patients [5, 6], or stage 3 and 4 of CKD [7, 8], reported a non-significant improvement on different indices of renal profiles following a period of probiotic consumption ranging from 2 to 6 months. The reason might be due to uremia which impairs intestinal barrier function and promotes inflammation throughout the gastrointestinal tract This alteration may interfere with the normal functions of the gut, causing disturbances in renal parameters. Manipulation of gut microbiota may positively impact renal profiles [3]
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