Table 6.

Pre-clinical and clinical applications of bovine colostrum in gastrointestinal diseases.

GI tract disease	Preclinical and clinical manifestations	Preclinical/Clinical studies					Reference
		Study Design	No. of patients enrolled in clinical trials (BC/placebo)	Endpoints observed	Effect	Dose
Acute infectious diarrhea	Eliminate pathogen, improve the intestinal barrier function, inhibit bacterial translocation, and reduce disease severity	Double-blind randomized-controlled trial	160 children (80/80)	Investigated for bacterial/viral causes of diarrhea (Salmonella, Shigella, E. coli, Campylobacter and Vibrio cholera; Rotavirus antigen in stool)	Lower frequency of vomiting and diarrhea	3G/sachet in 50 ml ordinary water	(Menchetti et al., 2016) (Barakat et al., 2020)
Helicobacter pylori infections	Inhibit the invasive capacity of pathogen bacteria, modulation of immune response, and favor mucosal repair	Randomized- controlled trial	C57BL/6 female mice subjected to 0.1 ml of 1×10(9) H. pylori	Bacterial load, gastric emptying time	Increased gastric emptying time (7.9 min)	0.1ml HNZ (hyperimmune bovine colostrum plus N-acetyl cysteine plus zinc)	(Rokka et al., 2008; Tran et al., 2010; Xu et al., 2015)
Immunodeficiency diarrhea	Reduced abdominal pain, diarrhea score, and fatigue, reduced daily stool frequency, and increased the body weight and body mass index	Randomized, single-blind trial	84 Adults (ColoPlus®/placebo) (43/41)	Daily stool frequency, body weight, body mass index, and baseline CD4+ count	Mean daily stool frequency (↓79%), self-reported fatigue (↓85%), mean CD4+ count (↑14%)	50 G, twice daily	(Florén et al., 2006; Kaducu et al., 2011)
Short bowel syndrome (SBS)	Support intestinal development and function in newborn, and also enhance intestinal adaptation and functions	Randomized, double-blind, crossover, pilot study	9 children	Intestinal absorption of energy and wet weight	No improvement in the wet weight or intestinal absorption	20% of the children’s basal fluid requirement (BFR)	(Ausholt et al., 2014; Støy et al., 2014; Shen et al., 2015)
Inflammatory bowel disease (IBD)	Reduced weight loss, decreased colon shortening, and improved the histologic severity of colon inflammation	Randomized- controlled trial	Six-week-old CD-1 mice	Clinical signs, histopathological characteristics, expression levels of toll-like receptor 4 (TLR4), pro- and anti-inflammatory cytokines, and microbial composition	↓TLR4 (p < 0.01), ↓Interleukin-1β (IL-1β; p < 0.001), ↓Interleukin-8 (IL-8; p < 0.001), and ↓Interleukin-10 (IL-10; p < 0.001)	100 mg of colostrum powder dissolved in 0.6 ml of physiological saline solution was given to each mouse	(Bellavia et al., 2014) (Menchetti et al., 2020)
Necrotizing enterocolitis (NEC)	Maturation of the digestive tract, balance gut microbiota, modulation of the intestinal immune system, and mucosal repair	Randomized-controlled trials	Four trials, 678 participants	Neonatal sepsis and necrotizing enterocolitis (NEC)	Late-onset sepsis (risk ratio (RR) 0.49, 95% confidence interval (CI) 0.32 to 0.73) NEC ≥ stage II RR 0.3 95% CI (0.12 to 0.76)	Oral lactoferrin 200mg/day	(Cairangzhuoma et al., 2013; Good et al., 2015);