Table 6 Safety and efficacy of Bacillus clausii as adjunct to ORS and zinc

Canani et al. (2007, Italy)

Prospective, multicenter, single-blind, RCT

100/92

Median 18 months

Duration, frequency and consistency of stool, hospital stay, safety and tolerability

All other outcomes were also similar in both groups. Bacillus clausii was well tolerated, with no observed AEs

Lahiri. (2008, India)

Phase III, controlled, open-label, multicenter, parallel-group, comparative, RCT

132/132

Mean 1.6 years

Duration, frequency and consistency of stool, vomiting, tolerability and AE

Duration and frequency of stool lower in experimental group

Lahiri, et al. (2015, India)

Open-label, prospective, RCT

69/62

6 months to 12 years

Duration and frequency of diarrhea, hospitalization and cost

Duration: 22.64 h vs 47.05 h;

Hospital stay: 2.78 d vs 4.30 d (p < 0.01);

Cost reduced by 472 Indian rupees

Lahiri, et al. (2015, India)

Open-label, Prospective, RCT

80/80

Up to 6 years

Duration and frequency of diarrhea

Duration: In study group, 22.26 h vs 34.16 h;

Frequency of stools, 1.15 vs 1.70

(p < 0.05)

Maugo. (2012, Kenya)

Randomized, double blind, placebo-controlled

51/51

6 to 59 months

Duration, frequency of diarrhea and hospitalization

Duration: Shorter in study group, 9.15 h;

Frequency of stools: Significant decrease in frequency in study group, on day 3 (2.74 [1.81] motions) vs 3.80 [2.70] motions in placebo group, mean absolute difference = 1.05 motions; p = 0.033) and on day 4 (1.45 [1.13] motions vs 2.35 [2.19] motions in placebo group, mean absolute difference = 0.9 motions; p = 0.018) vs placebo group

Urtula, Dacula. (2008, Philippines)

Monocentric, RCT

35/35

NR

Duration, frequency of diarrhea and hospitalization

Significant difference in duration (13.92 h);

Shorter hospital stay in B. clausii group