Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

NACompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

September 30, 2014

Conditions
HIV-associated Enteropathy
Interventions
OTHER

Serum-derived bovine immunoglobulin protein isolate (SBI)

SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.

OTHER

Placebo

Matching placebo

Trial Locations (10)

33166

Miami Springs

33308

Therafirst, Fort Lauderdale

45206

Cincinnati

48201

Detroit

76107

Fort Worth

90015

AIDS Research Alliance, Los Angeles

94110

Univ of California SF, San Francisco

95817

Univ of California Davis CARES Clinic, Sacramento

600654

Chicago

02461

Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Entera Health, Inc

INDUSTRY

NCT01828593 - Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy | Biotech Hunter | Biotech Hunter