Table 4.
Details of studies in other indications.
| Reference [Language] |
Study Dates | Population | Study Design Arms, n |
Probiotic Regimen | Results (vs. Control) | Adverse Events |
|---|---|---|---|---|---|---|
| Xi, 2013 [33] [Chinese] (Thrush) |
January 2011–December 2012 | Children 1–26 months old oral candidiasis infection |
Randomized, controlled 2% NaHCO₃ + nystatin + Pro, n = 35 2% NaHCO₃ + nystatin, n = 35 |
1 sachet BID Orally. For 14 days |
Higher total effective rate (94.3% vs. 77.1%, p ≤ 0.05). Lower recurrence rate (2.9% vs. 17.1%, p ≤ 0.05). |
None observed. |
| Li, 2017 [34] [Chinese] (Eczema) |
August 2014–January 2016 | Children 1–24 months old infantile eczema |
Randomized, controlled Topical treatment + Probiotic, n = 38 Topical treatment, n = 38 |
1 sachet BID, for 2 weeks |
Lower EASI scores at 2 weeks after treatment (p < 0.05). Higher total effective rate (92.1% vs. 65.7%, p < 0.01). |
None observed. |
| Wu, 2014 [36] [Chinese] (IDA) |
June 2010–April 2013 | Children 6–60 months old Nutritional iron deficiency anemia |
Randomized, controlled Iron dextran, n = 71 Iron dextran + Probiotic, n = 76 |
1 sachet QD, for 8 weeks |
Higher total effective rate (76.3% vs. 60.6 %; χ2 = 4.236, p = 0.040). | Decreased cases of side effects of Iron dextran (13.2% vs. 25.4%; p = 0.06). |
| Yang, 2015 [37] [Chinese] (IDA) |
February 2011–December 2013 | Children 6–60 months old Nutritional iron deficiency anemia |
Randomized, controlled Iron dextran, n = 76 Iron dextran + Probiotic, n = 76 |
1 sachet BID, for 8 weeks |
Higher markedly effective rate (75% vs. 55.3%; χ2 = 6.453, p = 0.011). | Decreased cases of side effects of iron dextran (17.1% vs. 30.3%; p = 0.06). |
| Wei, 2018 [35] [Chinese] (IDA) |
January 2015–December 2016 | Children 7–72 months old Nutritional iron deficiency anemia |
Randomized, Controlled Iron dextran, n = 30 Iron dextran + Probiotic, n = 30 |
1 sachet BID, for 8 weeks All received also Smecta® and antibiotics |
Total effective rate 10% higher in probiotic vs. control (96.7% vs. 86.7%; p > 0.1). | Decreased cases of side effects of iron dextran (20% vs. 40%; p = 0.09). |
| Huang and Ouyang, 2015 [38] [Chinese] (GI function; NEC) |
August 2011–August 2013 | Premature newborns (1000–1500 g; mean 34 weeks gestational age) | Randomized, placebo-controlled Placebo, n = 30 Probiotic, n = 30 |
0.5 sachet BID, for 2 weeks |
Reduced feeding intolerance vs. control (36.7% vs. 70%; p = 0.0104). Nonsignificant reduction in NEC incidence in probiotic (2/30; 6.7%) vs. control (5/30; 16.7%). Nonsignificant reduction in duration of hospital stay in probiotic (40.1 ± 15.6 d) vs. control (47.3 ± 16.7 d). |
One death (3.3%) in the probiotic group, 2 deaths in the control group (6.7%). Parenteral nutrition-associated cholestasis: 1 case (3.3%) in probiotic vs. 3 cases (10%) in control (p = 0.2755). |
| Gao, 2015 [39] [Chinese] (Jaundice) |
December 2013–December 2013 | Healthy full-term neonates gestational age 37–42 weeks (mean 40 weeks), birth weight 2500–4000 g |
Randomized, placebo-controlled Placebo, n = 500 Probiotic, n = 500 |
1 sachet BID, for 7 days after birth |
Similar time of onset of jaundice between groups (p > 0.05), with significantly lower incidence in probiotic (9%) vs. placebo (17%); p < 0.001. Similar daily percutaneous bilirubin levels until day 5 (p > 0.05), with a significant reduction in bilirubin levels in probiotic on treatment days 6 and 7 vs. placebo (p < 0.05). |
Similar between groups (erythema, vomiting, diarrhea; all p > 0.05). |
| Qiu, 2020 [30] [Chinese] (Jaundice) |
September 2017–May 2018 | Healthy full-term neonates gestational age 37–41 weeks, aged ≤3 days, with neonatal hyperbilirubinemia developing within 24 h of birth |
Randomized, controlled Blue light phototherapy, n = 32 Blue light phototherapy + Probiotic, n = 32 |
1 sachet BID, for 5 days |
Significant decrease in total and unconjugated bilirubin levels in probiotic vs. controls at day 3 and day 5 (p < 0.05). Significant increase in catalase levels vs. baseline at day 5 (p < 0.05) in the probiotic group, but no change in controls. |
n.r. |
BID, twice a day; IDA, iron deficiency anemia; NEC, necrotizing enterocolitis, n.r., not reported; QD, once daily; TID, three times per day.