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Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entera Health, Inc
ClinicalTrials.gov Identifier:
NCT01828593
First received: April 8, 2013
Last updated: April 11, 2016
Last verified: April 2016
Results First Received: February 9, 2016  
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
Condition: HIV-associated Enteropathy
Interventions: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consists of 2 phases, the Placebo-controlled (PC) phase and the Placebo-free (PF) extension phase. Participants were randomized in a 1:1:2:2 ratio into 4 groups: Placebo for 4 week PC phase followed by either 2.5g or 5.0g BID for 20 week PF phase or SBI 2.5g or 5.0g BID for 4-week PC phase followed by 2.5g or 5.0g for 20 week PF phase.

Reporting Groups
  Description
Placebo Matching Placebo
SBI 2.5 g

Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g

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.

SBI 5.0g

Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g

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.


Participant Flow for 2 periods

Period 1:   Placebo-Controlled Phase
    Placebo   SBI 2.5 g   SBI 5.0g
STARTED   36   34   33 
COMPLETED   36   34   32 
NOT COMPLETED   0   0   1 

Period 2:   Placebo-Free Phase
    Placebo   SBI 2.5 g   SBI 5.0g
STARTED   0   55   47 
COMPLETED   0   49   41 
NOT COMPLETED   0   6   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matching Placebo
SBI 2.5 g

Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g

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.

SBI 5.0g

Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g

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.

Total Total of all reporting groups

Baseline Measures
   Placebo   SBI 2.5 g   SBI 5.0g   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   34   33   103 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.8  (6.8)   50.9  (6.7)   50.7  (8)   51.1  (7.1) 
Gender 
[Units: Participants]
       
Female   8   13   11   32 
Male   28   21   22   71 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   4   5   2   11 
Not Hispanic or Latino   32   29   31   92 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   1   0   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   21   20   22   63 
White   14   14   10   38 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Years with HIV 
[Units: Years]
Mean (Standard Deviation)
 16  (7.6)   16.9  (6.3)   17.9  (6.3)   16.9  (6.76) 
Years with HIV-associated diarrhea 
[Units: Years]
Mean (Standard Deviation)
 4.4  (5.4)   6.9  (7.3)   6.6  (6.7)   5.9  (6.54) 
Baseline Plasma CD4+ cell count 
[Units: Cells/microliter]
Mean (Standard Deviation)
 629  (307)   746  (324)   671  (319)   682  (317) 
Plasma viral load 
[Units: copies/mL]
Mean (Standard Deviation)
 24  (11)   27  (22)   28  (28)   26  (21) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Daily Unformed Bowel Movements   [ Time Frame: Baseline and 4 weeks ]

2.  Other Pre-specified:   Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)   [ Time Frame: Baseline and 4 weeks ]

3.  Other Pre-specified:   Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)   [ Time Frame: Baseline and 6 months ]

4.  Other Pre-specified:   Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities in Biopsy Subjects   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Trials
Organization: Entera Health
phone: 515-963-7565
e-mail: audrey.shaw@enterahealth.com



Responsible Party: Entera Health, Inc
ClinicalTrials.gov Identifier: NCT01828593     History of Changes
Other Study ID Numbers: EH6001
Study First Received: April 8, 2013
Results First Received: February 9, 2016
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board