Table 1 Clinical studies assessing survival of orally-administered immunoglobulin preparations through the digestive 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 | 2Â 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 | 2Â 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 | 4Â g Ig or 16Â 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 | 14.2Â g IgG or 3.4Â 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 | 50Â mg/kg body weight | IgG (% NR), S | 1-80Â 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 (1994) – Unpublished, Data on File.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 | 0.5Â g, 2.5Â g or 10Â g IgG | IgG (% NR), C | <0.01% | NR | Bogstedt, et al. (1997) [19] |
Adult (8), healthy | Bovine | Liquid | 7.65Â g IgG | IgG, C | <0.1% | No | Lissner, et al. (1998) [20] |