The use of endotoxin neutralization as a biomarker for intestinal wall damage

A method of determining the effectiveness of a therapeutic agent for treating intestinal wall damage comprising:

• a) administering a therapeutic agent to the subject;
• b) heating a first biological sample from the subject after treatment with the therapeutic agent;
• c) adding a selected amount of exogenous endotoxin to the first sample of step b);
• d) detecting exogenous endotoxin in the first sample from step c);
• e) determining the amount of undetected exogenous endotoxin in the first sample by subtracting the detected exogenous endotoxin from step d) from the total exogenous endotoxin added in step c);
• f) acidifying a second biological sample from a subject after treatment with the therapeutic agent;
• g) adding the selected amount of exogenous endotoxin to the second sample of step f);
• h) detecting exogenous endotoxin in the second sample from step g);
• i) determining the amount of undetected exogenous endotoxin in the second sample by subtracting the detected exogenous endotoxin from step h) from the total exogenous endotoxin added in step g);
• and
• j) calculating a percentage of protein endotoxin neutralization, utilizing the following equation:
• ((amount of undetected exogenous endotoxin the second sample−amount of undetected exogenous endotoxin in the first sample)/selected amount of exogenous endotoxin)×100;
• wherein a decrease in the percentage of protein endotoxin neutralization after treatment as compared to a control indicates that the therapeutic agent is effective for treating intestinal wall damage.

A method of treating intestinal wall damage in a subject comprising:

• a) calculating levels of protein endotoxin neutralization, undetected exogenous endotoxin and enzymatic endotoxin neutralization in a biological sample from the subject;
• and
• b) calculating an endotoxin neutralization ratio using the following formula:
• (protein endotoxin neutralization+undetectable exogenous endotoxin)/enzymatic endotoxin neutralization)
• a ratio of about 5 or greater indicating that the subject has intestinal wall damage;
• and
• c) administering a therapeutic agent for treating intestinal wall damage to the subject.