The product information provided in this site is intended for residents of the United States.

Resources

Associations & Organizations

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

 

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only — they do not constitute endorsements of those other sites.

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 prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.

Please see full Product Information

To report suspected adverse reactions, contact Entera Health, Inc. 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.