Table 1.
Human clinical trials investigating microbial treatments for skin conditions.
| Route of Administration | Condition | Author, year | Study Type | Participants | Intervention | Key findings |
|---|---|---|---|---|---|---|
| Oral | Atopic Dermatitis (AD) | Navarro-Lopez et al., 2018 [59] | RCT | 50 children (4–17 years) with AD | Bifidobacterium lactis CECT 8145, Bifidobacterium longum CECT 7347, and Lactobacillus casei CECT 9104 (109 total colony-forming units), daily for 12 weeks (n = 26) |
Significant reduction in disease severity and topical steroid use in probiotic group Nonsignificant reduction of inflammatory markers (IL-4, IL-5, and IL-13) in probiotic group versus placebo |
| Wu et al., 2017 [60] | RCT | 66 children (4–48 months) with AD | Lactobacillus rhamnosus (MP108) (350 mg), daily for 8 weeks (n = 33) |
Significant reduction in disease severity in probiotic group versus placebo No difference in topical steroid use between groups |
||
| Woo et al., 2010 [61] | RCT | 75 children (2–10 years) with AD | Lactobacillus sakei KCTC 10755BP (5 ×109 colony-forming units), twice daily for 12 weeks (n = 41) | Significant reduction in disease severity and inflammatory markers (CCL17 and CCL27) in probiotic group versus placebo | ||
| Wang and Wang, 2015 [62] | RCT | 220 children (1–18 years) with AD | Lactobacillus paracasei (LP) (2 × 109 colony-forming units) or Lactobacillus fermentum (LF) (2 × 109 colony-forming units) or LP + LF mixture (4 × 109 colony-forming units), twice daily for 12 weeks (n = 55 for each group) | Significant reduction in disease severity in all treatment groups versus placebo | ||
| Prakoeswa et al., 2017 [63] | RCT | 22 children (0–14 years) with AD | Lactobacillus plantarum IS-10506 (1010 colony-forming units/day), twice daily for 12 weeks (n = 12) | Significant reduction in disease severity and inflammatory markers (IL-4, IFN-γ, and IL-17) in probiotic group versus placebo | ||
| Han et al., 2012 [64] | RCT | 118 Children (1–13 years) with AD | Lactobacillus plantarum CJLP133 (0.5 × 1010 colony-forming units), twice daily for 12 weeks (n = 58) | Significant reduction in disease severity in probiotic group versus placebo and in total eosinophil count as compared to baseline | ||
| Yeşilova et al., 2012 [65] | RCT | 40 children (1–13 years) with AD | Bifidobacterium bifidum, Lactobacillus acidophilus, Lactobacillus casei, and Lactobacillus salivarius (2 × 109 colony-forming units), daily for 8 weeks (n = 20) | Significant reduction in disease severity and inflammatory markers (IL-5, IL-6, IFN-γ, and total serum IgE) in probiotic group versus placebo | ||
| Wickens et al., 2012 [66] | RCT | 474 infants at high risk of AD | Lactobacillus rhamnosus HN001 (6 × 109 colony-forming units/day) (n = 157) or Bifidobacterium animalis subsp lactis HN019 (9 × 109 colony-forming units/day) (n = 158), daily maternal supplementation from 35 weeks gestation until birth, continuing to 6 months in mothers after birth if breastfeeding, and infant supplementation until 2 years |
Significant reduction in the cumulative prevalence of AD and nonsignificant reduction in cumulative prevalence of severe disease in Lactobacillus rhamnosus HN001 group versus placebo No significant effects on any outcome measures were reported in Bifidobacterium animalis subsp lactis HN019 group |
||
| Nermes et al., 2011 [67] | RCT | 39 infants with AD | Lactobacillus rhamnosus GG (ATCC 53103) (3.4 × 109 colony-forming units/day) for 3 months (n = 19) |
Significant reduction in the proportions of IgA- and IgM-secreting cells in probiotic group Significant increase in the proportions of CD19+ CD27+ B cells in probiotic group No significant difference in reduction in disease severity between groups |
||
| Rautava et al., 2012 [68] | RCT | 205 mother-infant pairs (mothers with allergic disease and atopic senitization) | Lactobacillus rhamnosus LPR and Bifidobacterium longum BL999 (LPR + BL999) (n = 73) or Lactobacillus paracasei ST11 and Bifidobacterium longum BL999 (n = 70) (1 × 109 colony-forming units), daily maternal supplementation for 2 months before delivery and during first 2 months of breastfeeding | Significant reduction in the risk of developing AD during first 24 months of life in both probiotic groups versus placebo | ||
| Kim et al., 2010 [69] | RCT | 112 pregnant women (with a family history of allergic disease) | Bifidobacterium bifidum BGN4, Bifidobacterium lactis AD011, and Lactobacillus acidophilus AD031 (1.6 × 109 colony-forming units of each strain), daily from 8 weeks before delivery up to 6 months after delivery (n = 57) | Significant reduction in the prevalence and cumulative incidence of AD at 1 year in probiotic group versus placebo | ||
| Dotterud et al., 2010 [70] | RCT | 278 pregnant women | Lactobacillus rhamnosus GG (1010 colony-forming units), Lactobacillus acidophilus La‐5 (109 colony-forming units) and Bifidobacterium animalis subsp. lactis Bb‐12 (1010 colony-forming units), daily from 36 weeks of gestation to 3 months postnatally during breastfeeding (n = 138) | Significant reduction in the cumulative incidence of AD in children at 2 years of age versus placebo | ||
| Ou et al., 2012 [71] | RCT | 191 pregnant women (with atopic diseases) | Lactobacillus rhamnosus GG(ATCC 53103) (1 × 1010 colony-forming units), daily from 24 weeks gestation until delivery, and to 6 months to breastfeeding mothers or non-breastfeeding neonates (n = 95) | No significant difference in the incidence of moderate to severe AD or plasma IgE in infants at 6, 18 and 36 months | ||
| Cabana et al., 2017 [72] | RCT | 184 infants at high risk of AD (mothers with asthma) | Lactobacillus rhamnosus GG (10 billion colony-forming units), daily for first 6 months of life (n = 92) | No significant difference in the cumulative incidence of AD at 2 years of age | ||
| Boyle et al., 2011 [73] | RCT | 250 pregnant women (carrying infants at high risk of allergic disease) | Lactobacillus rhamnosus GG (1.8 × 1010 colony-forming units/day), from 36 weeks gestation until delivery (n = 125) |
No difference in the prevalence of AD during the first 12 months of life No significant difference in levels of inflammatory markers (IL-10, IL-13, TNF-α and IFN- γ) in infants whose pregnant mothers received probiotic (n = 31 versus placebo n = 30) |
||
| Allen et al., 2014 [74] | RCT | 454 mother-infant pairs | Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20 (total of 1010 organisms/day), maternal supplementation from 36 weeks gestation and infant supplementation to 6 months (n = 220) | No difference in the cumulative frequency of AD at 2 years | ||
| Gore et al., 2012 [75] | RCT | 137 infants (3–6 months) with AD | Lactobacillus paracasei CNCM I-2116 (1010 colony-forming units) (n = 45) or Bifidobacterium lactis CNCM I3446 (1010 colony-forming units) (n = 45), daily for 12 weeks | No significant difference in disease severity between groups | ||
| Wu et al., 2012 [76] | RCT | 54 children (2–14 years) with AD | Lactobacillus salivarius (2 × 109 colony-forming units) plus fructo-oligosaccharide (475 mg) (synbiotic) or fructo-oligosaccharide (475 mg) alone (prebiotic), twice daily for 8 weeks (n = 27 in each group) | Significant reduction in disease severity in synbiotic group versus prebiotic group | ||
| Gerasimov et al., 2010 [77] | RCT | 90 children (1–3 years) with AD | Lactobacillus acidophilus DDS-1, Bifidobacterium lactis UABLA-12 (total 5 billion colony-forming units) plus fructo-oligosaccharide (50 mg) (synbiotic), twice daily for 8 weeks (n = 43) | Significant reduction in disease severity and use of topical corticosteroids in treatment group versus placebo | ||
| Farid et al., 2011 [78] | RCT | 40 infants and children (3 months to 6 years) with AD | Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus (total 1 billion colony-forming units) and fructo-oligosaccharide (synbiotic), twice daily for 8 weeks (n = 19) | Significant reduction in disease severity in treatment group versus placebo | ||
| Grüber et al., 2010 [79] | RCT | 830 infants with low atopy risk | Mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides (total 8 g/L) (prebiotics) (n = 414), offered up to first year | Significant reduction in AD occurrence up to the first birthday in prebiotic group versus placebo | ||
| Shafiei et al., 2011 [80] | RCT | 41 infants (1–36 months) with AD | 1 × 109 CFU of seven strain probiotics plus fructo-oligosaccharides (990 mg) (synbiotic),daily for 2 months (n = 20) | No significant difference in reduction of disease severity between groups | ||
| Van Der Aa et al., 2010 [81] | RCT | 90 infants (<7 months) with AD | Bifidobacterium breve M‐16 V 1.3 × 109 colony-forming units/100 mL and a galacto‐/fructo-oligosaccharide mixture (0.8 g/100 mL), (approx. 778 mL daily) for 12 weeks (n = 46) | No significant difference in reduction of disease severity between groups | ||
| Drago et al., 2011 [89] | RCT | 38 adults (18–46 years) with AD | Lactobacillus salivarius LS01 (1 × 109 colony forming units/g), twice daily for 16 weeks (n = 19) | Significant improvement in disease severity and quality of life in probiotic group versus placebo | ||
| Acne | Jung et al., 2013 [82] | RCT, open-label | 45 females (18–35 years) with acne | Probiotic (Lactobacillus acidophilus (5 billion colony-forming units/capsule), Lactobacillus del-brueckii subsp. bulgaricus (5 billion colony-forming units/capsule), and Bifidobacterium bifidum (20 billion colony-forming units/capsule)) or minocycline (standard treatment) or minocycline plus probiotic (probiotic taken twice daily) for 12 weeks (n = 15 in each group) |
Significant improvement in disease severity in all treatment groups Significant improvement in disease severity in minocycline plus probiotic group versus other treatment groups |
|
| Fabbrocini et al., 2016 [83] | RCT, pilot study | 20 adults with acne | Lactobacillus rhamnosus SP1 (3 × 109 colony-forming units/day) for 12 weeks (n = 10) | Significant reduction in disease severity in probiotic group versus placebo | ||
| Kim et al., 2010 [85] | RCT | 36 males (18–30 years) with acne | Lactoferrin (200 mg) (prebiotic) daily for 12 weeks (n = 18) | Significant improvement in disease severity in treatment group versus placebo | ||
| Intestinal borne dermatoses | Manzhalii et al., 2016 [84] | RCT | 57 adults (18–42 years) patients with erythematous papular-pustular rash | Escherichia coli Nissle 1917 (2.5–25 × 109 colony-forming units/capsule), 2 capsules daily for 1 month (n = 37) | Significant amelioration or complete recovery in 89 % of patients with acne, popular pustular rosacea and seborrhoeic dermatitis in probiotic group versus 56 % in placebo | |
| Plaque psoriasis | Groeger et al., 2013 [87] | Interventional study | 26 adults (18–65 years) with plaque psoriasis | Bifidobacterium infantis 35264 (1 × 1010 colony‐forming units), daily for 8 weeks (all patients received the treatment) | Significant reduction in the plasma concentration of C‐reactive protein and proinflammatory cytokine (TNF‐α) compared to baseline | |
| Navarro-López et al., 2019 [88] | RCT | 90 adults (18–70 years) with plaque psoriasis | 1:1:1 of Bifidobacterium longum CECT 7347, Bifidobacterium lactis CECT 8145 and Lactobacillus rhamnosus CECT 8361 (total of 1 × 109 colony-forming units/capsule), daily for 12 weeks (n = 46) | Significant reduction in disease severity and lower risk of relapse after 6 months in probiotic group versus placebo | ||
| Hand dermatitis | Gulliver et al., 2018 [90] | Open-label | 30 adults (over 18 years) with hand dermatitis | Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 (30 billion colony-forming units/capsule), daily for 12 weeks (all patients received the treatment) |
Significant improvement in 27% of subjects 23% of subjects achieved clear or almost clear hands by 12 weeks Pruritus was improved with 59% of symptomatic patients within 2 weeks |
|
| Dandruff | Reygagne et al., 2017 [91] | RCT | 60 males (18–60 years) with dandruff | Lactobacillus paracasei NCC 2461 ST11 (1 × 109 colony-forming units), daily for 56 days (n = 30) | Significant clinical improvement in probiotic group versus placebo | |
| Topical | Atopic Dermatitis | Blanchet-Réthoré et al., 2017 [92] | Open-label | 31 adults (18–75 years) with AD | Heat-treated Lactobacillus johnsonii NCC 533 (3.1 × 1011 colony-forming units/g), twice daily for 3 weeks (all patients received the treatment) | Significant reduction in Staphylococcus aureus load and disease severity in treated versus untreated lesions |
| Myles et al., 2018 [93] | Open-label phase I/II trial |
10 adults and 5 children (9–14 years) with AD |
Roseomonas mucosa (dose escalation from 103–105 colony-forming units), adults = twice weekly for 6 weeks, children = twice weekly for 12 weeks (all patients received the treatment) | Significant reduction in disease severity and Staphylococcus aureus load compared to baseline measurements | ||
| Butler et al., 2020 [94] | RCT, proof-of-concept | 34 adults (18–70 years) with AD | Lactobacillus reuteri DSM 17938 (minimum 1 × 108 colony-forming units/g), twice daily for 8 weeks (n = 17) | Significant improvement in disease severity after 4 and 8 weeks of use as compared to baseline measurements | ||
| Nakatsuji et al., 2017 [95] | Interventional study | 5 adults with AD | Antimicrobial Coagulase-Negative Staphylococci (Staphylococcus hominis and Staphylococcus epidermidis (1 × 105 colony-forming units/cm2)) isolated from human skin, single dose on one forearm (vehicle control on other forearm) | Significant reduction in Staphylococcus aureus burden on treatment forearm versus vehicle control forearm | ||
| Acne | AOBiome Therapeutics, 2017 [96] | RCT, Phase 2b | 358 adults with acne | Nitrosomonas eutropha (dose not specified), twice daily for 12 weeks | Significant reduction in disease severity in probiotic group versus vehicle control | |
| Muizzuddin et al., 2012 [97] | Interventional study | 29 females (25–55 years) with acne | Lactobacillus plantarum (at 1% or 5% concentration) or Triclosan (an antibacterial agent) (at 0.1%), twice daily for 2 months (groups of 9–10 each) | Significant reduction in disease severity in probiotic (5 % concentration) group as compared to baseline measurements | ||
| Bateni et al., 2013 [98] | RCT | 26 females (18–39 years) with acne | Glucomannan hydrolysates (prebiotic) (5% (w/v)) or standard treatment (antibiotics), twice daily for about 6 weeks | Significant improvement in disease severity at 20 and 40 days for both treatments | ||
| Reactive skin | Guéniche et al., 2010 [99] | RCT | 66 females with reactive skin | Bifidobacterium longum reuter lysate (5 %), twice daily for 2 months (n = 33) | Significant decrease in skin sensitivity and increased skin resistance to physical and chemical aggression in probiotic group versus placebo |
Significant findings are reported at p ≤ 0.05.
RCT randomized controlled trial, AD atopic dermatitis.