Randomized control trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by enterotoxigenic Escherichia coli in volunteers

Figures & data

Figure 1. Study design.

Table I. Summary of results of study 1: prophylactic efficacy of hyperimmune bovine colostrum powder (400 mg doses) and placebo against infection with enterotoxigenic E. coli strain, H10407.

	Treatment group
	Placebo	Colostrum	p*
Number of volunteers	15	15
Number of volunteers with diarrhea	11 (73%)	1 (7%)	0.0005
Number of diarrheal stools/volunteer (mean ± SEM)	4.4 ± 0.9	0.4 ± 0.4	0.0004
Mean number of diarrheal stools per volunteer with diarrhea (mean and range)	6 (2–8)	6 (6)	NS
Abdominal pain	5 (33%)	0 (0%)	0.04
ETEC H10407 isolated from feces after challenge	15 (100%)	12 (80%)	NS

*Fisher's exact test or Student's t-test (two-tailed) as appropriate.

NS, not significant.

Table II. Summary of results of study 2: prophylactic efficacy of different doses of hyperimmune bovine colostrum powder with or without sodium bicarbonate buffer against infection with enterotoxigenic E. coli strain, H10407.

	Treatment group
	Group 1: Placebo tid	Group 2: Colostrum 400 mg tid + buffer	Group 3: Colostrum 200 mg tid	Group 4: Colostrum 400 mg tid
Number of volunteers	14	14	14	15
Number of volunteers with diarrhea	12 (86%)	2 (14%), p = 0.0004*	5 (36%), p = 0.02	3 (20%), p = 0.007
Number of diarrheal stools/volunteer (mean ± SEM)	3.9 ± 0.8	0.5 ± 0.3, p = 0.0005	1.8 ± 0.8, p = 0.07	0.9 ± 0.5, p = 0.003
Mean number of diarrheal stools per volunteer with diarrhea (mean and range)	5 (3–10)	3.5 (3–4)	5 (2–7)	4.7 (2–7)
Abdominal pain	5 (36%)	0 (0%), p = 0.04	2 (14%), p = 0.04	0 (0%), p = 0.02
ETEC H10407 isolated from feces after challenge	12 (86%)	14 (100%)	14 (100%)	12 (80%)

*All tests of significance compared the results of active treatment with the placebo group and were calculated by using Fisher's exact test or Student's t-test (two-tailed) as appropriate.