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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 (1994) – Unpublished, Data on File.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.