Table 2.
Details of studies on diarrhea of various etiologies.
| Reference [Language] |
Study Dates | Population | Study Design Arms, n |
Probiotic Regimen | Results (vs. Control) | Adverse Events |
|---|---|---|---|---|---|---|
| Cui, 2003 [22] [Chinese] |
September 2002–November 2002 | Children 6–24 months old RV-ag+ diarrhea Onset < 72 h |
Randomized, controlled Ribavirin + Pro, n = 62 Ribavirin + Lacidophilin, n = 60 |
<12 months: 1 sachet QD 12–24 months: 1 sachet BID Orally in warm water or milk Until resolution or up to 72 h |
Shorter duration of diarrhea (39.3 ± 17.1 vs. 63.8 ± 22.9 h) Higher total effective rate (93.5% vs. 61.7%; p < 0.01) |
n.r. |
| Li, 2008 [24] [Chinese] |
June 2005–December 2007 | Children 0–60 months old RV-ag+ diarrhea |
Randomized, controlled Ribavirin + Pro, n = 39 Ribavirin alone, n = 39 |
1 sachet BID Orally. 7 days |
Higher total effective rate (94.9% vs. 74.3%; p < 0.05) | n.r. |
| Jiang, 2008 [26] [Chinese] |
December 2006–June 2008 | Children 3–24 months old Persistent diarrhea |
Randomized, active control Pro, n = 32 GoldenBifido, n = 20 |
<6 months: 0.5 sachet BID 6–12 months: 1 sachet BID 12–24 months: 1–2 sachet BID Until resolution |
Shorter duration of diarrhea (7.14 ± 0.78 vs. 12.6 ± 1.75 d; p < 0.001) Higher total effective rate (91% vs. 65%; p < 0.01) |
n.r. |
| Yang, 2010 [25] [Chinese] |
January 2008–October 2009 | Children 6–30 months old RV-ag+ diarrhea |
Randomized, controlled CST + Pro (in formula), n = 58 CST (breastfed or formula), n = 40 |
1 sachet QD Orally In lactose-free formula Duration not stated |
Shorter duration of diarrhea (2.8 ± 1.1 vs. 4.9 ± 2.6 d; p< 0.01) Shorter hospital stay (5.5 ± 1.7 vs. 8.5 ± 2.3 d; p < 0.01). Higher total effective rate (94.8% vs. 77.5%; p ≤ 0.05) |
n.r. |
| Wang, 2012 [20] [Chinese] |
May 2010–December 2010 | Children 3–36 months old Non-infectious diarrhea Onset < 72 h |
Randomized, controlled Smecta® + Pro, n = 104 Smecta®, n = 90 |
<12 months: 0.33 sachet TID 12–24 months: 0.5 sachet BID 24–36 months: 1 sachet BID Orally. 3 days |
Higher markedly effective rate in three age groups (p > 0.05): < 12 months: 78.8% vs. 74.2% 12–24 months: 79.1% vs. 74/3% 24–36 months: 82.1% vs. 75% |
None observed |
| Luo, 2013 [19] [Chinese] |
April 2010–February 2011 | Children 4–36 months old Non-infectious diarrhea Onset < 72 h |
Randomized, controlled Smecta® + Pro, n = 75 Smecta®, n = 68 |
<12 months: 0.33 sachet TID 12–24 months: 0.5 sachet BID 24–36 months: 1 sachet BID Orally. 3 days |
Higher effective rate (94.8% vs. 73%; p < 0.05) |
n.r. |
| Gao, 2013 [15] [Chinese] |
January 2011–January 2012 | Children 0–36 months old Non-infectious diarrhea |
Randomized, controlled Smecta® + Pro, n = 43 Smecta®, n = 43 |
<12 months: 0.33 sachet TID 12–36 months: 0.5 sachet TID Orally. 3 days |
Higher total effective rate (90.7% vs. 62.8%; p < 0.05) | None observed |
| Wu, 2013 [21] [Chinese] |
April 2011–December 2011 | Children 2–36 months old Non-infectious diarrhea Onset < 72 h |
Randomized, controlled Smecta® + Pro, n = 84 Smecta®, n = 64 |
<12 months: 0.33 sachet TID 12–24 months: 0.5 sachet BID 24–36 months: 1 sachet BID Orally. 3 days |
Higher total effective rate (90.5% vs. 75%; p < 0.05) | n.r. |
| Jin, 2014 [23] [Chinese] |
October 2011–June 2013 | Children 5–52 months old (mean 17.3 mo) RV-ag+ diarrhea. Onset < 72 h |
Randomized, active control Smecta® + Ribavirin + Pro, n = 48 Smecta® + Ribavirin, n = 48 |
0.5–1 sachet BID Orally. In warm water. Duration not stated. Fluids provided as needed |
Shorter time to symptom relief (diarrhea, 31.6 ± 5.2 h vs. 34.6 ± 4.1 h; p< 0.05) Higher total effective rate (91.7% vs. 75.0%; p < 0.05) |
n.r. |
| Liu, 2015 [18] [Chinese] |
May 2011–May 2014 | Children 3–38 months old Non-infectious diarrhea |
Randomized, controlled Smecta® + Pro, n = 75 Smecta®, n = 75 |
<12 months: 0.33 sachet TID 12–24 months: 0.5 sachet BID 24–36 months: 1 sachet BID Orally. 3 days |
Higher markedly effective rate (72% vs. 45.33%; p < 0.05) Higher total effective rate (96% vs. 84%; p < 0.05) Reduced diarrhea frequency (p < 0.05), time to diarrhea relief (p < 0.05) and symptom disappearance (p < 0.05) in the probiotic group |
n.r. |
| Liang, 2018 [17] [Chinese] |
February 2015–May 2017 | Children 3–39 months old Non-infectious diarrhea |
Randomized, active control Smecta® + Probiotic, n = 43 Smecta® alone, n = 43 |
<12 months: 0.33 sachet TID 12–24 months: 0.5 sachet BID 24–36 months: 1 sachet BID Orally. 3 days |
Higher total effective rate (95.35% vs. 79.07%; p < 0.05) | n.r. |
| Li, 2020 [16] [Chinese] |
January 2019–February 2020 | Children 6–37 months old Non-infectious diarrhea |
Randomized, controlled Smecta® + Pro, n = 49 Smecta®, n = 49 |
<12 months: 0.33 sachet TID 12–24 months: 0.33 or 0.66 sachet TID 24–36 months: 1 sachet TID Orally. 3 days |
Higher total effective rate (95.91% vs. 83.67%; p < 0.05) | n.r. |
BID, twice a day; CST, comprehensive standard therapy (as needed; Smecta®, fluids, antibiotics, etc.); n.r., not reported; Pro, Probiotic (Biostime®); RV-ag+, positive for fecal rotavirus antigen; TID, three times per day; QD, once daily.