Helpful Links
Rome III Disorders and Criteria
http://www.romecriteria.org/criteria/
Crohn’s & Colitis Foundation of America
http://www.ccfa.org/
Clinical Studies
Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
http://clinicaltrials.gov/ct2/show/NCT02017405
Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
http://clinicaltrials.gov/ct2/show/NCT01828593
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
http://clinicaltrials.gov/ct2/show/NCT01867606
Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD (SBI for COPD)
http://clinicaltrials.gov/ct2/show/NCT02067377
Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) 5.0 g BID on Nutritional Status in Subjects With IBS-D
https://clinicaltrials.gov/ct2/show/NCT02163213
Educational Resources
UNC Center for Functional GI & Motility Disorders
http://www.med.unc.edu/ibs
Inflammatory Bowel Disease Health Center
http://www.webmd.com/ibd-crohns-disease/
Government
Centers for Disease Control and Prevention. Hygiene-related Diseases.
https://www.cdc.gov/healthywater/hygiene/disease/chronic_diarrhea.html
Irritable Bowel Syndrome. National Institute of Diabetes and Digestive and Kidney Diseases.
http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/
Irritable bowel syndrome: What helps – and what doesn’t. PubMed Health. https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0072599/
Irritable Bowel Syndrome (IBS). PubMed Health.
https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0024780/
Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition US Food and Drug Administration.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm
Medical Foundations
Irritable Bowel Syndrome (IBS). The Cleveland Clinic Foundation.
http://my.clevelandclinic.org/health/articles/irritable-bowel-syndrome-ibs
Irritable Bowel Syndrome. Mayo Foundation for Medical Education and Research.
http://www.mayoclinic.org/diseases-conditions/irritable-bowel-syndrome/basics/definition/con-20024578
Irritable Bowel Syndrome Self Help and Support Group
http://www.ibsgroup.org
IBS Patient
http://www.ibspatient.org
Inflammatory Bowel Disease (IBD). Mayo Foundation for Medical Education and Research.
http://www.mayoclinic.org/diseases-conditions/inflammatory-bowel-disease/basics/definition/con-20034908
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Intended Use
EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.
Important Safety Information
EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the supervising physician.
EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.
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To report suspected adverse reactions, contact Entera Health, LLC at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
The product information provided in this site is intended for residents of the United States.
EnteraGam® is manufactured and
distributed by Proliant Health & Biologicals, LLC
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Ankeny, IA 50021
ENT100H0121 01/21
