Trial record 7 of 8 for:
gluten | Open Studies | United States
Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
This study is currently recruiting participants.
Verified April 2013 by Entera Health, Inc
Sponsor:
Entera Health, Inc
Information provided by (Responsible Party):
Entera Health, Inc
ClinicalTrials.gov Identifier:
NCT01828593
First received: April 8, 2013
Last updated: May 1, 2013
Last verified: April 2013
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Purpose
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g BID and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
| Condition | Intervention |
|---|---|
|
HIV-associated Enteropathy |
Other: Serum-derived bovine immunoglobulin protein isolate (SBI) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy. |
Resource links provided by NLM:
Further study details as provided by Entera Health, Inc:
Primary Outcome Measures:
- Frequency of daily bowel movements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma concentration of Vitamin D and E [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
- Nutrient absorption [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
- Body measurements: weight, mid-upper arm circumference (MUAC), waist:hip ratio, body mass index (BMI), total body water (TBW), fat-free mass (FFM), body cell mass (BCM) [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
- Daily stool consistency [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
- Gastrointestinal symptoms [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | |
|
Active Comparator: SBI 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
|
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.
|
|
Active Comparator: SBI 5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
|
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.
|
Detailed Description:
This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of HIV-1 infection
- Plasma HIV viral load ≤40 copies/mL
- Maintained virologic suppression for 1 year
- Stable ART regimen
- History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration
Exclusion Criteria:
- Positive stool test for pathogenic bacteria, C. difficile or ova and parasites
- Conditions that require chronic therapy that is known to alter gut microbiota
- Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01828593
Contacts
| Contact: Susan S Cloninger, BS, RAC | 919-319-0067 ext 16 | scloninger@tabclinical.com |
| Contact: Audrey L Shaw, RN, PhD | 919-971-8000 | audrey.shaw@enterahealth.com |
Locations
| United States, California | |
| Recruiting | |
| Los Angeles, California, United States, 90015 | |
| Not yet recruiting | |
| Palm Springs, California, United States, 92262 | |
| Not yet recruiting | |
| Sacramento, California, United States, 95817 | |
| Not yet recruiting | |
| San Francisco, California, United States, 94110 | |
| United States, Florida | |
| Recruiting | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 600654 | |
| United States, Massachusetts | |
| Not yet recruiting | |
| Boston, Massachusetts, United States, 02461 | |
| United States, Michigan | |
| Not yet recruiting | |
| Detroit, Michigan, United States, 48201 | |
| United States, Ohio | |
| Not yet recruiting | |
| Cincinnati, Ohio, United States, 45206 | |
| United States, Texas | |
| Not yet recruiting | |
| Ft. Worth, Texas, United States, 76107 | |
Sponsors and Collaborators
Entera Health, Inc
Investigators
| Principal Investigator: | David M Asmuth, M.D. | University of California, Davis |
More Information
No publications provided
| Responsible Party: | Entera Health, Inc |
| ClinicalTrials.gov Identifier: | NCT01828593 History of Changes |
| Other Study ID Numbers: | EH6001 |
| Study First Received: | April 8, 2013 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Intestinal Diseases HIV Enteropathy Gastrointestinal Diseases Digestive System Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Immunoglobulins Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013