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EnteraGam® HIV Enteropathy Clinical Study Results

  • EnteraGam® significantly decreased stool frequency and steadily improved stool consistency1,*
  • 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%
Median Changes From Baseline to End of Study1,*,†

hcp-hiv-page_median-chnage-chart_no-charthead

All patients experienced marked improvements in daily GI-related symptoms in as early as 3 weeks1

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
  1. 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.
  2. EnteraGam [product information]. Ankeny, IA: Entera Health, Inc.; October 2016.

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.