Probiotics for glycemic control in patients with type 2 diabetes mellitus: protocol for a systematic review

Thanitsara Rittiphairoj,Krit Pongpirul,Noel T Mueller,Tianjing Li

doi:10.1186/s13643-019-1145-y

Abstract

BackgroundType 2 diabetes mellitus (T2DM) is a major public health problem worldwide. It is characterized by the increased concentration of glucose in the blood and leads to damage of the body system, especially blood vessels and nerves. Lifestyle modification is often combined with anti-diabetic therapy as the standard of care for T2DM to maintain the proper blood glucose and to prevent long-term diabetic complications. The role of probiotics in improving glycemic control has been investigated in several randomized controlled trials (RCTs). Previous systematic reviews and meta-analyses, including different sets of trials have concluded an overall beneficial effect of probiotics in patients with T2DM. At least two RCTs with a longer treatment duration have been published since the publication of existing reviews.MethodsWe will conduct a systematic review of RCTs that evaluated the effectiveness and safety of probiotics for glycemic control in T2DM patients. Primary outcomes are fasting blood glucose and glycosylated hemoglobin (A1c). Secondary outcomes are plasma insulin, blood lipid profile, adverse events, and cost associated with the intervention and hospital visits. We will search PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, and trial registries. Two reviewers will independently screen titles and abstracts, review full texts, extract information, and assess the risk of bias. We will summarize the results both qualitatively and statistically. We will use random-effects model for meta-analysis.DiscussionThis systematic review aims to examine whether probiotics are effective and safe for glycemic control in T2DM patients. Evidence generated from this review will inform clinical and public health practice and future research.Systematic review registrationCRD42019121682

Highlights

Type 2 diabetes mellitus (T2DM) is a major public health problem worldwide
Description of the condition Diabetes mellitus is a chronic disease characterized by impaired insulin sensitivity or production, which leads to increased blood glucose concentration and eventually damage to the body system, especially blood vessels and nerves [1]
Patients with poorly controlled blood glucose are at risk for both microvascular complications such as renal, retinal, and neuropathy diseases, as well as macrovascular complications such as peripheral vascular diseases and coronary diseases

Summary

Methods

We have registered the systematic review with PROSPERO registration number CRD42019121682 and have followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement [44]. Two review authors will independently extract the following data items: (1) general information, including trial name and registration information; (2) trial characteristic, including trial design, location, setting, and inclusion/exclusion criteria; (3) characteristic of participants, including age, sex, race/ethnicity, severity of the diabetes, and comorbidities; (4) details of interventions, including type, strain, composition of probiotics, dose, duration of treatment, co-interventions (anti-diabetic standard therapy); (5) details of comparison interventions; (6) outcomes as described under “type of outcome measure” section. We will present results as risk ratio with 95% CIs. Assessment of heterogeneity We will assess clinical and methodological heterogeneity by examining participant characteristics, probiotics type, duration of probiotics usage and dose, outcomes, and the study of design. Additional file 1: PRISMA-P (Preferred Reporting Items for Systematic review and Meta-analysis Protocols) 2015 checklist.

Background