Table 1.
Characteristics of included randomized controlled trials.
| Study | Country | Design | Population characteristics | Age | Control | Probiotics | Study duration | n | Intestinal barrier function | Gut microbiota | Other indicators |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 18 | Canada | Randomized, double blind, placebo-controlled trial | Critically ill patients | Control: 64.9 ± 16.9 Probiotics: 60.4 ± 17.9 |
Placebo | VSL#3: Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. Bulgaricus), Bifidobacterium (B. longum, B. breve, and B. infantis) and Streptococcus salivarius subsp. Thermophilus (2 sachets twice daily) | 7 days | Control: 9 Intervention: 10 |
L/M | — | CRP, IgA, IgG |
| 19 | Netherlands | Randomized, placebo-controlled, double-blind, multicenter trial | Patients with a first episode of predicted severe acute pancreatitis | 60.5 ± 16.0 | Placebo | Ecologic 641: a mixture of 6 lactobacillus, lactococcus, or bifidobacteriae | 7 days | Control: 144 Intervention: 152 |
IFABP, PEGs, NOx | — | — |
| 20 | Italy | Crossover randomized double-blind controlled trial |
Patients with irritable bowel syndrome | 48 ± 11 | Placebo (maltodextrins, corn starch, silicon dioxide) | LBB: Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 with vitamin B6 (1 sachet pack daily) | 60 days | Control: 25 Intervention: 25 |
L/M, sucralose recovery | — | — |
| 21 | China | Randomized, parallel-group, controlled trial | Patients with colorectal cancer | Control: 59.8 ± 18.7 Probiotics: 60.3 ± 17.2 |
Placebo | Combined Clostridium Butyricum and Bifidobacterium Capsules,Live (capsule: 3 capsules thrice daily) | 12 days | Control: 35 Intervention: 35 |
TER, Mannitol permeability | Bifidobacteria, Lactobacilli, Enterobacterium |
— |
| 22 | Netherlands | Randomized placebo-controlled study | Patients with migraine | Control: 38 (18–70) Probiotics: 42 (18–69) |
Placebo (2g of the carrier of the probiotic product; maize starch and maltodextrin powder) |
Bifidobacterium bifidum W23, B. lactis W52, Lactobacillus acidophilus W37, Lactob. brevis W63, Lactob. casei W56, Lactob. salivarius W24, Lactococcus lactis W19 and Lactoc. lactis W58 (2g sachets once daily) | 12 weeks | Control: 29 Intervention: 31 |
L/M, Zonulin in feces and serum | — | CRP, IL-6, IL-10, TNF-α |
| 23 | Austria | Randomized, double blind, placebo-controlled study | Patients with cirrhosis | Control: 56 (50; 63) Probiotics: 60 (54; 64) |
Placebo | Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 (6g daily) | 6 months | Control: 36 Intervention: 44 |
L/M, DAO, ET Zonulin in fecal, sucralose recovery | — | CRP |
| 24 | Republic of Korea | Randomized, double blind, placebo-controlled study | Patients with chronic liver disease | Control: 53.3 ± 9.8 Probiotics: 54.4 ± 8.4 |
Placebo | Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus rhamnosus, and Streptococcus thermophilus (capsule: twice daily) | 4 weeks | Control: 25 Intervention: 25 |
L/M | Bifido group, Lacto group |
— |
| 25 | Austria | Randomized, double-blinded, placebo-controlled trial | Endurance trained men | Control: 38.2 ± 4.4 Probiotics: 37.6 ± 4.7 |
Placebo (a matrix cornstarch, maltodextrin, vegetable protein) | Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Enterococcus faecium W54, Lactobacillus acidophilus W22, Lactobacillus brevis W63, and Lactococcus lactis W58 (4g daily) | 14 weeks | Control: 12 Intervention: 11 |
Zonulin in fecal | — | IL-6, TNF-α |
| 26 | Austria | An open label, randomized pilot study | Patients with metabolic syndrome | Control: 54.5 ± 8.9 Probiotics: 51.5 ± 11.4 |
Standard treatment | YAKULT light: L. casei Shirota (liquid: 3 bottles of 65 ml daily) | 3 months | Control: 15 Intervention: 13 |
Recovery of saccharose, L/M, DAO | — | — |
| 27 | China | Double-center and double-blind randomized clinical trial |
Patients with colorectal liver metastases | Control: 60.16 ± 16.20 Probiotics: 65.62 ± 18.18 |
Placebo (maltodextrin) | Lactobacillus plantarum, Lactobacillus acidophilus-11 and Bifidobacterium longum-88 (capsules: 2g daily) | 16 days | Control: 58 Intervention: 59 |
ET, Zonulin in serum | — | — |
| 28 | China | Randomized, double-blind, placebo-controlled, prospective study | Patients undergoing elective colorectal surgery |
Control: 65.7 ± 9.9 Probiotics: 65.3 ± 11.0 |
Placebo (maltodextrin) | Lactobacillus plantarum, Lactobacillus acidophilus-11 and Bifidobacterium longum-88 (capsules: 2g daily) | 16 days | Control: 50 Intervention: 50 |
L/M, TER, I-FABP | Bifidobacterium, Lactobacillus, Enterobacteriaceae | — |
| 29 | China | Double-center and double-blind randomized clinical trial |
Patients with colorectal cancer | Control: 62.28 ± 12.41 Probiotics: 66.06 ± 11.02 |
Placebo (maltodextrin) | Lactobacillus plantarum, Lactobacillus acidophilus-11 and Bifidobacterium longum-88 (capsules: 2g daily) | 16 days | Control: 75 Intervention: 75 |
L/M, serum zonulin, TER | — | — |
| 30 | UK | A prospective randomized trial | Critically ill patients. | Control; 71 (28-87) Probiotics: 71 (28-90) |
Conventional therapy | ProViva: L. plantarum 299v (liquid: 500 ml daily) | 15 days | Control: 51 Intervention: 52 |
L/R | — | IL-6 |
| 31 | China | Prospective, randomized, single-blinded, parallel design clinical trial | Patients with acute pancreatitis | Control: 58.4 ± 19.1 Probiotics: 54.3 ± 13.1 |
Parenteral nutrition | Lactobacillus plantarum (liquid: 100ml daily through the nasojejunal tube) | 1 week | Control: 38 Intervention: 36 |
L/R | Bifidobacteria, Lactobacteria, Enterococci | CRP |
| 32 | Iran | Randomized, double−blind, placebo−controlled trial |
Critically ill patients | Control: 35.60 ± 5.03 Probiotics: 33.60 ± 5.50 |
Placebo | VSL#3: Lactobacillus casei, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus delbrueckii subsp., Bifidobacterium longum, Bifidobacterium breve, and Bifidobacterium infantis and Streptococcus salivarius subsp. Thermophilus. (2 sachets daily) |
7 days | Control: 20 Intervention: 20 |
— | — | IL−6 |
| 33 | India | Randomized, double−blind, placebo−controlled trial |
Patients with acute pancreatitis | Control: 40.19 ± 17.43 Probiotics: 41 ± 20.72 |
Placebo | Lactobacillus acidophilus, Bifidobacterium longus, Bifidobacterium bifidum, and Bifidobacterium infantalis (4 sachets daily) | 7 days | Control: 26 Intervention: 24 |
L/M | — | hsCRP, IgG, IgM |
| 34 | Australia | Double-blind, placebo-controlled cross-over trial | Male runners | 27 ± 2 | Placebo (skim milk powder) |
Lactobacillus acidophilus, L. rhamnosus, L. casei, L. plantarum, L. fermentum, Bifidobacterium lactis, B. breve, B. bifidum and Streptococcus thermophilus (capsule: 1 capsule daily) | 4 weeks | Control: 10 Intervention: 10 |
L/R, LPS | — | IgM, IL-6, IL-10, TNF-α |
| 35 | India | Randomized, double-blind, placebo-controlled trial | Children with gastroenteritis | 6 months -5 years | Placebo | Lactobacillus rhamnosus GG (1 capsule given once daily in boiled and cooled milk) | 4 weeks | Control: 59 Intervention: 65 |
L/M | — | — |
| 36 | Canada | Randomized, double-blind, placebo-controlled study | Patients with untreated celiac disease | Control; 40 (20-71) Probiotics: 46 (29-62) |
Placebo (rice flour, dehydrated potato powder, cellulose powder, and hydroxypropyl-methylcellulose) |
Bifidobacterium infantis natren life start strain super strain (capsule: 2 capsules thrice daily) |
3 weeks | Control: 10 Intervention: 12 |
L/M | — | IL-6 |
| 37 | Italy | Randomized, double-blind, placebo-controlled, cross-over trial | Healthy adults who self-reported psychological stress | 20-35 | Placebo (liquid mixture) |
Lactoflorene® Plus: Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI431®, Bacillus coagulans BC513, zinc and B vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) (liquid: two 10ml bottles daily) | 45 days | Control: 25 Intervention: 25 |
— | — | IgA, IL-10, TNF-α |
| 38 | Austria | Randomized, double blind, placebo-controlled pilot study | Patients with early sepsis | 54 (47; 60) | Placebo | Lactobacillus plantarum W1, Lactobacillus paracasei W20, Bifidobacterium bifidum W23, Lactobacillus salivarius W24, Lactobacillus acidophilus W37, Bifidobacterium lactis W51, Enterococcus faecium W54, Lactobacillus acidophilus W55, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 (5g twice daily) | 28 days | Control: 4 Intervention: 5 |
DAO, ET, Zonulin in stool |
— | — |
| 39 | Thailand | Randomized, double-blind, placebo-controlled study | Patients with type 2 diabetes mellitus | Control: 61.78 ± 7.73 Probiotics: 63.50 ± 5.94 |
Placebo (corn starch) |
L. paracasei HII01 (50 × 109 CFU/day) | 12 weeks | Control: 18 Intervention: 18 |
ZO-1, LPS | — | hsCRP, IgA, IL-6, IL-10, TNF-α |
| 40 | USA | Randomized, double blind, placebo-controlled study | Division I male baseball athletes | 20.1 ± 1.5 | Placebo (maltodextrin) | Bacillus subtilis DE111 (capsule: 1.2 billion CFU/capsule) | 12 weeks | Control: 12 Intervention: 13 |
Zonulin in serum | — | IL-10, TNF-α |
| 41 | China | Single-blind, randomized controlled trial | Critically ill patients. | Control: 81 (61; 95) Probiotics: 81 (70; 96) |
Placebo | Clostridium butyricum (tablet: 1 sachet thrice daily) | 14 days | Control: 33 Intervention: 27 |
DAO, LPS | — | IL-10, TNF-α |
| 42 | Netherlands | Randomized, double blind, placebo-controlled study | Patients with ulcerative colitis | Control: 51.1 ± 11.9 Probiotics: 51.8 ± 13.3 |
Placebo (maize starch and maltodextrins) |
Ecologic® 825: Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, and Lactococcus lactis W19 (2 sachets daily of 3g) | 12 weeks | Control: 12 Intervention: 13 |
L/R, S/E, Zonulin in serum and faecal | — | IL-6, IL-10, TNF-α |
| 43 | China | Randomized, parallel-group, controlled trial | Patients undergo colonic surgery | 67.3 (37–82) | Preoperative bowel preparation methods | Lactobacillus acidophilus LA11 (granule; 2g daily) | ≥5 days | Control: 30 Intervention: 30 |
— | — | IgA |
| 44 | China | Single-center prospective randomized control study | Patients with colorectal cancer | Control: 61.5 (46.0–82.0) Probiotics: 67.5 (45.0–87.0) |
Placebo (maltodextrins) | B longum, L acidophilus and Enterococcus faecalis (capsule: 3 capsules thrice daily) | 3 days | Control: 30 Intervention: 30 |
D-LA, ET | — | CRP, IgA, IgG, IgM, IL-6 |
| 45 | China | Randomized, parallel-group, controlled trial | Patients with diarrhea secondary to leukemia chemotherapy | Control: 9.26 ± 1.84 Probiotics: 9.17 ± 1.92 |
Routine symptomatic support | Bifidobacterium longum, Lactobacillus acidophilus and Enterococcus faecalis (capsule: 1 capsule twice daily) | 2 weeks | Control: 45 Intervention: 45 |
DAO, D-LA, ET | Bifidobacterium, Lactobacillus, Enterococcus, Enterobacteriaceae | IL-6, TNF-α |
"__" means not mentioned.