1. female subjects who are pregnant or breast-feeding. 2. subject is enrolled in another randomized clinical trial. 3. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. 4. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. 5. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. 6. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. 7. subject has a history of allergy or intolerance to beef or to any ingredient in the product. 8. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 9. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 10. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.

1. female subjects who are pregnant or breast-feeding. 2. subject is enrolled in another randomized clinical trial. 3. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. 4. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. 5. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. 6. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. 7. subject has a history of allergy or intolerance to beef or to any ingredient in the product. 8. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 9. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 10. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.

female subjects who are pregnant or breast-feeding. subject is enrolled in another randomized clinical trial. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. subject has a history of allergy or intolerance to beef or to any ingredient in the product. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.

female subjects who are pregnant or breast-feeding. subject is enrolled in another randomized clinical trial. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. subject has a history of allergy or intolerance to beef or to any ingredient in the product. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.

1. female subjects who are pregnant or breast-feeding. 2. subject is enrolled in another randomized clinical trial. 3. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. 4. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. 5. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. 6. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. 7. subject has a history of allergy or intolerance to beef or to any ingredient in the product. 8. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 9. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 10. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.

1. female subjects who are pregnant or breast-feeding. 2. subject is enrolled in another randomized clinical trial. 3. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. 4. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. 5. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. 6. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. 7. subject has a history of allergy or intolerance to beef or to any ingredient in the product. 8. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 9. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. 10. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.