EnteraGam® HIV Enteropathy Clinical Study Results
- EnteraGam® significantly decreased stool frequency and steadily improved stool consistency*1
- Patients taking EnteraGam® had 4 fewer bowel movements per day, as well as improved consistency
- Mucosal CD4+ lymphocyte densities increased by a median of 140 cells/mm2, an increase of 51%
No serious adverse events or drug interactions have been reported with EnteraGam®2
*Results from an 8-week, open-label study of EnteraGam® in patients who had severe HIV-associated enteropathy (N = 8) with approximately 5 to 6 watery stools per day. Subjects received 2.5 g of EnteraGam® twice daily.
†GI symptom questionnaire assessed cramping, urgency, incontinence, and nocturnal diarrhea with a possible score of 0 to 24, with < 2 being normal.
‡Using a scale of 1 (formed) to 6 (watery).
References
- Asmuth D, Netanya S. Utay NS, Somsouk M, et al. Oral bovine immunoglobulin reduces immune activation in HIV+ immune nonresponders. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA.
- EnteraGam® [product information]. Ankeny, IA: Entera Health, Inc.; October 2020.
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.
Please see .
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
©2021 Proliant Health & Biologicals, LLC
Ankeny, IA 50021
ENT100H0121 01/21
