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. 2020 Jun 23;102:178–192. doi: 10.1016/j.tifs.2020.06.010

Table 1.

Summary of clinical trials based on applications of prebiotics and probiotics aimed for the treatments of different diseases.

S. No Study design Name of disease No. of patients Age group (in years) Duration of the study Name of pre & prebiotic used Control group Main outcome of the study References
1 Randomized Control Trial (RCT) Irritable bowel syndrome (IBS) 39 19–75 4 weeks Lactobacillus acidophilus, L. rhamnosus, Bifidobacterium breve, B. actis, B. longum, and Streptococcus thermophilus Placebo Significantly enhanced the fecal contents of most probiotic strains.
Promoted diarrhea-symptom scores in the IBS patients.
Yoon et al. (2015)
2 Double Blind Clinical Trial Inflammatory bowel disease (IBD) 105 36–38 8 weeks Lactobacillus acidophilus La-5 and Bifidobacterium BB-12 Placebo Significantly increased the numbers of Lactobacillus, Bifidobacterium, and Bacteroides in the treated group Shadnoush, Hosseini et al. (2015)
3 Randomized, Double-Blind, Placebo-Controlled Trial Infantile colic 24 <1 (3 weeks-6 months) 21 days Lactobacillus reuteri DSM 17938 Placebo Significantly improved colic symptoms Chau, Lau et al. (2015)
4 RCT Necrotizing enterocolitis (NEC) 400 <1 (<32 weeks) 8 weeks Bifidobacteriumlactis as probiotic and inulin as prebiotic Placebo Probiotic (Bifidobacterium lactis) and synbiotic (Bifidobacterium lactis plus inulin) but not prebiotic (inulin) alone decrease NEC Dilli, Aydin et al. (2015)
5 RCT Nonalcoholic fatty liver disease (NAFLD) 42 18–65 8 weeks Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus Placebo Significantly reduced insulin, insulin resistance, TNF-a, and IL-6 decreased Sepideh, Karim et al. (2016)
6 RCT Rheumatoid arthritis (RA) 46 20–80 8 weeks Lactobacillus casei 01 Placebo No significant effect on oxidative status was observed between the treated and placebo groups Vaghef-Mehrabany, Homayouni-Rad et al. (2016)
7 Randomized, Double-Blind,
Placebo-Controlled Trial
RA 30 25–70 8 weeks Lactobacillus acidophilus,
Lactobacillus casei, Bifidobacterium bifidum
Placebo Significantly improved Disease Activity Score of 28 Joints (DAS-28).
Significantly lowered serum insulin levels, homeostatic model assessment-B cell function (HOMA-B), and serum high-sensitivity C-reactive protein (hs-CRP) concentrations
Zamani, Golkar et al. (2016)
8 Randomized, Double-Blind,
Placebo-Controlled Trial
Alzheimer's Disease (AD) 60 60–95 12 weeks Lactobacillusacidophilus, Lactobacilluscasei,Bifidobacteriumbifidum, andLactobacillusfermentum Placebo Significantly improved Mini-mental state examination (MMSE)score in the treated group.
No considerable effect on oxidative stress and inflammation, fasting plasma glucose, and other lipid profiles was observed
Akbari, Asemi et al. (2016)
9 Randomized, Double-Blind,
Placebo-Controlled Trial
Parkinson disease (PD) 120 71.8 ± 7.7 4 weeks Streptococcus salivarius subsp thermophilus, Enterococcus faecium, Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus plantarum,
Lactobacillus paracasei, Lactobacillus delbrueckii subsp bulgaricus, and Bifidobacterium as probiotics and Psyllium fiber as prebiotic
Placebo Significantly improved constipation in PD patients. Barichella, Pacchetti et al. (2016)
10 Randomized, Double-Blind, Placebo-Controlled Trial Overweight diabetic patients with coronary heart disease (CHD). 30 40–85 12 weeks Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, as probiotics and Inulin as prebiotic Placebo Significantly decreased plasma glucose, serum insulin concentrations.
Improved insulin sensitivity.
Tajabadi-Ebrahimi, Sharifi et al. (2017)
11 Double-Blind, Placebo-Controlled Trial IBS 54 18–70 8 weeks Lactobacillus rhamnosus
L. casei, L. paracasei, L. plantarum L. acidophilus, Bifidobacterium bifidum, B. longum, B. breve, B. infantis, Streptococcus thermophilus, L. bulgaricus and Lactococcus lactis
Placebo No significant difference was observed between the treated and placebo groups Hod, Sperber et al. (2017)
12 Randomized Triple-Blind
Placebo-Controlled Trial
NAFLD 64 10–18 12 weeks Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium bifidum, Lactobacillus rhamnosus Placebo Significantly decreased levels of alanine aminotransferase, mean aspartate aminotransferase, mean cholesterol, low-density lipoprotein-C, and triglycerides as well as waist circumference in the intervention group.
No significant change in weight, body mass index, and body mass index z score was observed between the two groups.
Famouri, Shariat et al. (2017)
13 Double-Blind, Placebo-Controlled Trial Overweight or obesity 22 7–12 12 weeks Oligofructose-enriched inulin Placebo Significantly decreased body weight z-score, percent body fat, and percent trunk fat and levels of interleukin 6 and serum triglycerides in the treated group. Nicolucci, Hume et al. (2017)
14 Randomized, Double-Blind, Placebo-Controlled Trial IBS 22 30–50 10 weeks Bifidobacterium longum NCC3001 (BL) Placebo BL reduced depression but not anxiety scores and increases quality of life in patients with IBS Pinto-Sanchez, Hall et al. (2017)
15 Randomized Double-Blind Placebo-Controlled Clinical Trial Diabetes 60 54.0 ± 16.0 12 weeks Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum Placebo Significantly decreased fasting plasma glucose, homeostasis model of assessment-estimated insulin resistance, homeostasis model of assessment-estimated beta-cell function and HbA1c, and improved quantitative insulin sensitivity check index.
Significantly reduced serum high-sensitivity C-reactive protein, plasma malondialdehyde, subjective global assessment scores and total iron binding capacity, and a significant increase in plasma total antioxidant capacity
Soleimani, Mojarrad et al. (2017)
16 Randomized, Double-Blind Trial Overweight or obesity 21 20–59 8 weeks Lactobacillus acidophilus and casei; Lactococcus lactis; Bifidobacterium bifidum and lactis Placebo Significantly reduced the waist circumference, waist-height ratio, conicity index, and plasma polyunsaturated fatty acids and increased the activity of glutathione peroxidase. Gomes, de Sousa et al. (2017)
17 Double Blind Randomized Clinical Trial NAFLD 75 20–60 12 weeks Bifidobacterium longum (BL) and Lactobacillus acidophilus as probiotic and inulin high performance (HP) as prebiotic Placebo Supplementation with probiotics and/or prebiotics improved amino transferase enzymes, and supplementation with probiotics or pro- and prebiotics recovered the grade of fatty liver in NAFLD patients. Javadi, Ghavami et al. (2017)
18 Randomized, Double-Blind, Placebo-Controlled Trial Overweight and obese type-2 diabetes 60 30–55 45 days Sodium butyrate and inulin Placebo Significantly improved Akkermansia muciniphila percent change.
Significant decreased TNF-α mRNA, hs-CRP, MDA and diastolic blood pressure levels in the treated groups
Roshanravan, Mahdavi et al. (2017)
19 Randomized Controlled Clinical Trial Diabetic kidney disease (DKD) 48 32–68 8 weeks L plantarum A7 Placebo Improved oxidative stress factors among DKD patients Miraghajani, Zaghian et al. (2017)
20 Double Blind Randomized Clinical Trial NAFLD 84 20–60 12 weeks BL as probiotic and inulin as prebiotic Placebo Probiotic and prebiotic supplementation improved serum lipid profile and insulin resistance markers in NAFLD patients. Javadi, Ghavami et al. (2018)
21 Placebo-Controlled,
Double-Blind Randomized Controlled Trial
Major depressive disorder 81 18–50 8 weeks Lactobacillus helveticus and B.L. as probiotic and galactooligosaccharide as prebiotic Placebo Improved Beck Depression Inventory (BDI) score in the treatment group Kazemi, Noorbala et al. (2019)
22 Single-Blind, Parallel, Randomized, Placebo-Controlled Trial Overweight or obesity 41 30–65 12 weeks Bacillus coagulans BC30, 6086 as probiotic and β-glucans as prebiotic Placebo The formulated synbiotic pasta showed synbiotic exhibited beneficial effects on plasma resistin, plasma LDL/HDL cholesterol ratio, and plasma hs-CRP Angelino, Martina et al. (2019)
23 Double-Blind, Placebo-Controlled, Randomized Clinical Trial Overweight or obesity 50 20–60 12 weeks B. breve CBT
BR3, L. plantarum CBT LP3 as probiotic and fructo-oligosaccharide as prebiotic
Placebo Significantly improved obesity-related markers in obese people Song, Han et al. (2020)