Triple probiotic combination effect on metabolic, oxidative stress, and inflammatory parameters in diabetic population: Systematic review and meta-analysis

Table 1 PICOS criteria for study determination

Parameter	Description
Population	Adults with diabetes
Intervention	Fixed triple probiotic combination of Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum (either as single therapy or in combination with other therapies)
Comparator	Either placebo, any standard therapy alone, or any other supplementation other than the fixed triple probiotic combination of Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum
Outcomes	1 Glycaemic parameters
	a: Serum glucose level
	b: Serum insulin level
	c: Insulin resistance level (HOMA-IR score)
	d: Insulin sensitivity level (QUICKI score)
	e: Pancreatic β-cell functioning (HOMA-B score)
	2 Antioxidant parameters
	a: Total antioxidant capacity level
	b: Glutathione level
	c: Malondialdehyde level
	d: Nitric oxide level
	e: High sensitivity C-reactive protein level
	3 Lipid parameters
	a: Total cholesterol level
	b: Triglycerides level
	c: Low-density lipoprotein level
	d: Very low-density lipoprotein level
	e: High-density lipoprotein level
	f: Total cholesterol/High-density lipoprotein level ratio
Study design	Randomized controlled clinical study
Study questions	1 Is the triple probiotic combination effective in reducing insulin resistance and improving serum glucose and insulin level in patients with diabetes?
	2 Is the triple probiotic combination effective in reducing oxidative stress and improving antioxidant potential in patients with diabetes?
	3 Is the triple probiotic combination effective in improving lipid parameters in patients with diabetes?

HOMA-IR: Homeostatic model assessment for insulin resistance; HOMA-B: Homeostasis model assessment of β-cell function; QUICKI: Quantitative insulin-sensitivity check index.

Table 2 Characteristics of included studies

Ref.	Population	Age (range in years)	Gender	Sample size (active/control)	Intervention		Study duration
					Active group	Control group
Soleimani et al[29]	Dia-Hem	18–80	Male and female	30/30	Triple probiotic supplement (6 × 109 CFU)	No details present	12 weeks
Soleimani et al[30]	Dia-Hem	18–80	Male and female	30/30	Triple probiotic supplement (6 × 109 CFU) + Inulin 0.8 gm	Starch	12 weeks
Tajabadi-Ebrahimi et al[31]	Dia-CHD	40–85	No details present	30/30	Triple probiotic supplement (6 × 109 CFU) + Inulin 800 mg	Starch	12 weeks
Raygan et al[32]	Dia-CHD	40–85	No details present	30/30	Triple probiotic supplement (6 × 109 CFU)	No details present	12 weeks
Farrokhian et al[33]	Dia-CHD	40–85	Male and female	30/30	Triple probiotic supplement (6 × 109 CFU) + Inulin 800 mg	Starch	12 weeks

CFU: Colony-forming unit; Dia-Hem: Diabetics under hemodialysis; Dia-CHD: Diabetics with coronary heart disease.

Table 3 Quality assessment of included studies

Parameters	Ref.
	[29]	[30]	[31]	[32]	[33]
Eligibility criteria	1	1	1	1	1
Random allocation	1	1	1	1	1
Concealed allocation	1	1	1	1	1
Baseline similarity	1	1	1	1	1
Subject blinding	1	1	1	1	1
Therapist blinding	1	1	1	1	1
Assessor blinding	0	0	0	0	0
< 15% dropouts	1	1	1	1	1
Intention-to-treat analysis	1	1	1	1	1
Between-group statistics	1	1	1	1	1
Point measures and variability	1	1	1	1	1
Overall score	10	10	10	10	10