Table 3.
RCT aimed to evaluate the effects of synbiotics against NAFLD and NASH.
| Synbiotic | Design | Main Results | Reference |
|---|---|---|---|
| L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, and FOS | - 52 adult overweight and obese patients with NAFLD based on transient elastography and ALT > 60 U/L. - 28 weeks of supplementation (synbiotic or placebo; n = 26 per group) twice daily plus lifestyle modification (energy-balanced diet and physical exercise). - No liver biopsy during the study. |
- ↓ Fibrosis score (transient elastography) - ↓ Circulating levels of ALT, AST and GGT. - ↓ Blood levels of TNFα and CRP. - ↓ NF-kB p65 in PBMCs. - ↓ HOMA-IR and glucose. |
[108] |
| L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, and FOS | - 42 adult subjects with BMI ≤ 25 and with NAFLD based on transient elastography and ALT > 60 U/L. - 28 weeks of supplementation (synbiotic or placebo; n = 21 per group) twice daily plus lifestyle modification (energy-balanced diet and physical exercise). - No liver biopsy during the study. |
- ↓ Steatosis and fibrosis (transient elastography). - ↓ Circulating levels of glucose, TAGs, AST and CRP. - ↓ NF-kB p65 in PBMCs. |
[109] |
| L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, and FOS | - 74 adult individuals with NAFLD based on ultrasonography. - 8 weeks of supplementation (synbiotic, n = 38 or placebo, n = 36) once daily. - No liver biopsy during the study. - No dietary and physical exercise programs. |
- ↓ Steatosis severity (ultrasonography) in synbiotic group compared to baseline but not in comparison with the placebo group. - ↓Body weight compared to baseline. - No effects on circulating levels of ALT, AST and CRP. |
[110] |
| L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, and FOS | - 60 adult overweight and obese subjects and with NAFLD based on ultrasonography and ALT > 30 mg/dL - 8 weeks of supplementation (VitE, synbiotic, symbiotic + VitE or placebo; n = 15 per group) twice daily. - No liver biopsy or ultrasonography during the study. - No dietary and physical exercise programs. |
- ↓ Circulating levels of ALT, AST, ALP. - ↓ Blood levels of TNFα, leptin. - ↓ Circulating levels of TAGs, TC, LDL-C, APOB100/APOA1. - ↓ Circulating levels of glucose, insulin. - Synbiotic +Vit E produced a greater drop of the circulating levels of LDL-C, TNFα, ALT, AST, ALP, leptin, insulin and glucose than the symbiotic. |
[111,112] |
| B. longum and FOS | - 66 adult patients with biopsy-proven NASH, abnormal serum transferase levels and steatosis based on ultrasonography. - 4 initial weeks of lifestyle modification (energy-balanced diet and physical exercise). - 24 weeks of supplementation (synbiotic, n = 34 or placebo, n = 32) twice daily plus lifestyle modification. - Liver biopsy also performed at the end of the study. |
- ↓ Steatosis severity and NASH activity index (liver biopsy). - ↓ Circulating levels of AST, TNFα, CRP and LDL-C. - ↓ HOMA-IR. - ↓ Serum endotoxin. |
[113] |
| L. reuteri plus inulin and guar gum | - 50 adult patients with MetS and biopsy-proven NASH. - 3 months of supplementation (synbiotic, n = 27 or placebo, n = 23) twice daily plus lifestyle modification (hypocaloric diet). - No physical exercise program. - No liver biopsy during the study. |
- ↓ Steatosis severity (PDFF) in synbiotic group compared to baseline but not in comparison with the placebo group. - ↓Body weight, waist circumference and BMI compared to baseline. - ↑ Circulating levels of LPS (in both placebo and synbiotic groups). - ↓ Serum levels of uric acid - No effects on circulating levels of ALT, AST, ALP, GGT, glucose and lipids. |
[114] |
Abbreviations: ALT: Alanine aminotransferase; ALP: alkaline phosphatase; APOA1: Apolipoprotein A1; APOB100: apolipoprotein B100; AST: aspartate aminotransferase; BMI: body mass index; CRP: C-Reactive Protein; FOS: fructooligosaccharide; GGT: gamma-glutamyltransferase; HOMA-IR: homeostasis model assessment–estimated insulin resistance; LDL-C: low density lipoprotein colesterol; LPS: lipopolysaccharides; MetS: metabolic syndrome; NAFLD: nonalcoholic fatty liver disease; NASH: nonalcoholic steatohepatitis; NF-kB p65: p65 subunit of Nuclear factor k-B; PBMCs: peripheral mononuclear cells; PDFF: proton density fat fraction; RCT: randomized clinical trial; TC: total cholesterol; TNF-α: tumor necrosis factor-α; TAGs: triacylglycerides. ↓ means that there is a reduction in the value of the parameter.