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Table 1 Clinical studies assessing survival of orally-administered immunoglobulin preparations through the digestive tract in humans

From: Survival and digestibility of orally-administered immunoglobulin preparations containing IgG through the gastrointestinal tract in humans

Population (n), health status Donor species Preparation Amount of Ig ingested daily Material* Recovery Recovered immunological activity Reference
Infant (10), healthy Bovine Powder 2 g/kg IgG (70%), C 13% Yes (titer correlated with % IgG recovered) Zinkernagel, et al. (1972) [9]
Infant (6), healthy Human Liquid 1 – 8 ml/kg (152 – 1120 mg of IgG) IgG (~99%), S 4-12% Yes (titer, 1:2) Blum, et al. (1981) [10]
Infant (179), low birth weight Human Liquid 600 mg IgA (73%) –IgG (26%), S 1-10 mg/g of dry feces NR Eibl et al. (1988) [11]
Infant (164), rotaviral gastroenteritis Bovine (hyperimmunized) Liquid 2 g of concentrate/kg IgG (% NR), M 10% Yes (titer, 1:48) Hilpert, et al. (1987) [12]
Children (3), immune deficiency with chronic diarrhea/rotavirus Human Liquid 150 mg/kg IgG (% NR), S ~25% Yes (titer NR, recovery as intact immune complex, Ig + rotavirus) Losonsky, et al. (1985) [13]
Children (105), healthy Bovine (hyperimmunized) Liquid (one Powder Group) NR as gram of Ig Ig (% NR), C 5% Yes (titer correlated with initial dose) Pacyna, et al. (2001) [14]
Adult (65), cholera Bovine (hyperimmunized) Powder 4 g Ig or 16 g Ig IgG (~94%), C 10-20% Yes (titer NR) McClead, et al. (1988) [17]
Adult (7), healthy Bovine Powder 24.4 g Ig IgG (84%) – IgM (14%), C ~19% Yes (titer NR) Roos, et al. (1995) [4]
Adult (6), healthy Bovine (hyperimmunized) Powder 2.1 g IgG IgG (% NR), C 49% Yes (titer correlated with % IgG recovered) Warny, et al. (1999) [6]
Adult (6), healthy Bovine (hyperimmunized) Powder 14.2 g IgG or 3.4 g IgG IgG (% NR), C 1.6-32.7% Yes (titer NR) Kelly, et al. (1997) [5]
Adult (50), healthy & challenged with S. flexneri Bovine (hyperimmunized) Liquid NR as gram of Ig IgG (% NR), C ǂ Yes (titer, ≥ 1:8) Tacket, et al. (1992) [16]
Adult (72), bone marrow transplant patients Human Liquid 50 mg/kg body weight IgG (% NR), S 1-80 mg/dL of feces NR Copelan, et al. (1994) [18]
Adult (12), healthy Bovine Powder NR as gram of Ig IgG (% NR), S ǂ NR Hanning, et al. (1994) – Unpublished, Data on File.
Adult (4), healthy Bovine Powder 0.5 g, 2.5 g or 10 g IgG IgG (% NR), C <0.01% NR Bogstedt, et al. (1997) [19]
Adult (8), healthy Bovine Liquid 7.65 g IgG IgG, C <0.1% No Lissner, et al. (1998) [20]
  1. Amount collected from the ileum.
  2. ǂ Indicates the presence of immunoglobulin in stool.
  3. *S = serum; C = colostrum; M = milk concentrate.
  4. NR = Not Reported.