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Table 1 Patients’ baseline demographic and clinical characteristics

From: Efficacy and safety of Bacillus clausii (O/C, N/R, SIN, T) probiotic combined with oral rehydration therapy (ORT) and zinc in acute diarrhea in children: a randomized, double-blind, placebo-controlled study in India

 

B. clausii

(n = 229)

Placebo

(n = 228)

All

(n = 457)

Age, years

 Number of subjects

229

228

457

2.0 (1.1)

2.0 (1.1)

2.0 (1.1)

Age group, years [n (%)]

 Number of subjects

229

228

457

 < 2

112 (48.9)

122 (53.5)

234 (51.2)

 ≥ 2

117 (51.1)

106 (46.5)

223 (48.8)

Sex [n (%)]

 Number of subjects

229

228

457

 Male

113 (49.3)

112 (49.1)

225 (49.2)

 Female

116 (50.7)

116 (50.9)

232 (50.8)

No. of food intakes during the day

 Number of subjects

229

228

457

 

4.2 (1.8)

4.1 (1.8)

4.2 (1.8)

Breastfeeding status [n (%)]

 Number of subjects

229

228

457

 Yes

22 (9.6)

31 (13.6)

53 (11.6)

 No

111 (48.5)

108 (47.4)

219 (47.9)

 Mixed

96 (41.9)

89 (39.0)

185 (40.5)

Body weight, kg

 Number of subjects

227

227

454

 

12.2 (3.9)

12.0 (3.7)

12.1 (3.8)

Body weight percentile by category, kg [n (%)]

 Number of subjects

227

227

454

 < 5th

39 (17.2)

38 (16.7)

77 (17.0)

 > 5th–< 85th

119 (52.4)

119 (52.4)

238 (52.4)

 > 85th–< 95th

37 (16.3)

44 (19.4)

81 (17.8)

 > 95th

32 (14.1)

26 (11.5)

58 (12.8)

Body mass index, kg/m2

 Number of subjects

227

226

453

 

17.5 (5.0)

17.4 (3.6)

17.4 (4.4)

Temperature, °C

 Number of subjects

227

227

454

 

36.8 (0.4)

36.9 (0.4)

36.9 (0.4)

Systolic blood pressure, mmHg

 Number of subjects

227

226

453

 

99.4 (12.0)

100.4 (12.4)

99.9 (12.2)

Diastolic blood pressure, mmHg

 Number of subjects

227

226

453

 

63.5 (11.4)

63.9 (11.3)

63.7 (11.4)

Heart rate, beats/min

 Number of subjects

227

225

452

 

102.6 (15.8)

101.9 (16.9)

102.2 (16.3)

Respiratory rate, breaths/min

 Number of subjects

227

227

454

 

26.2 (6.4)

25.7 (6.5)

26.0 (6.5)

Medical history and disease characteristics

 Nausea and vomiting symptoms [n (%)]

  Number of subjects

49 (21.4)

42 (18.4)

91 (19.9)

 Gastrointestinal and abdominal painsa [n (%)]

  Number of subjects

2 (0.9)

2 (0.9)

4 (0.9)

 Duration of current diarrheab, hours

  Number of subjects

229

228

457

 

31.1 (9.3)

29.3 (8.7)

30.2 (9.0)

 No. of stools in last 24 h

  Number of subjects

229

228

457

 

6.3 (4.0)

6.6 (4.3)

6.5 (4.2)

 No. of stools in last 48 hc

  Number of subjects

229

228

457

 

10.2 (5.3)

10.1 (5.3)

10.1 (5.3)

 Viral status [n (%)]

  Number of subjects

229

228

457

  Viral

76 (33.2)

94 (41.2)

170 (37.2)

  Non-viral

153 (66.8)

134 (58.8)

287 (62.8)

  Not valid

0

0

0

  Not done

0

0

0

 Rotavirus and adenovirus test status [n (%)]

  Number of subjects

229

228

457

  Adenovirus positive

28 (12.2)

26 (11.4)

54 (11.8)

  Rotavirus positive

41 (17.9)

56 (24.6)

97 (21.2)

  Adenovirus and rotavirus positive

7 (3.1)

12 (5.3)

19 (4.2)

  Negative

153 (66.8)

134 (58.8)

287 (62.8)

  Not valid

0

0

0

  Not done

0

0

0

  1. All data in the table are expressed as mean (SD) unless otherwise stated
  2. aExcluding oral and throat
  3. bDuration of current diarrhea episode (hours) = (Date time of randomization – Date time of start time of current diarrhea episode)/3600
  4. cNumber of stools in the last 48 h includes stools in the last 24 h
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Tropical Diseases, Travel Medicine and Vaccines

ISSN: 2055-0936

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