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Trial record 10 of 29 for:    " April 07, 2013":" May 07, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01828593
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : March 8, 2016
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Entera Health, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition HIV-associated Enteropathy
Interventions Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
Other: Placebo
Enrollment 103
Recruitment Details  
Pre-assignment Details 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 wk PC phase followed by either 2.5g or 5.0g BID for 20 wk PF phase or SBI 2.5g or 5.0g BID for 4-wk PC phase followed by 2.5g or 5.0g for 20 wk PF phase.
Arm/Group Title Placebo SBI 2.5 g SBI 5.0g
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Matching Placebo

Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 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.

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.

Period Title: Placebo-Controlled Phase
Started 36 34 33
Completed 36 34 32
Not Completed 0 0 1
Period Title: Placebo-Free Phase
Started 0 [1] 55 [2] 47 [3]
Completed 0 [1] 49 [2] 41 [3]
Not Completed 0 6 6
[1]
Placebo subjects took either SBI 2.5 or 5.0 g in the placebo-free phase
[2]
SBI 2.5 g includes SBI 2.5 plus placebo who started taking SBI at Wk 4
[3]
SBI 5.0 g includes SBI 5.0 plus placebo who started taking SBI at Wk 4
Arm/Group Title Placebo SBI 2.5 g SBI 5.0g Total
Hide Arm/Group Description Matching Placebo

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.

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 of all reporting groups
Overall Number of Baseline Participants 36 34 33 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 34 participants 33 participants 103 participants
51.8  (6.8) 50.9  (6.7) 50.7  (8) 51.1  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 33 participants 103 participants
Female
8
  22.2%
13
  38.2%
11
  33.3%
32
  31.1%
Male
28
  77.8%
21
  61.8%
22
  66.7%
71
  68.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 33 participants 103 participants
Hispanic or Latino
4
  11.1%
5
  14.7%
2
   6.1%
11
  10.7%
Not Hispanic or Latino
32
  88.9%
29
  85.3%
31
  93.9%
92
  89.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 33 participants 103 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.8%
0
   0.0%
1
   3.0%
2
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
21
  58.3%
20
  58.8%
22
  66.7%
63
  61.2%
White
14
  38.9%
14
  41.2%
10
  30.3%
38
  36.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Years with HIV  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 34 participants 33 participants 103 participants
16  (7.6) 16.9  (6.3) 17.9  (6.3) 16.9  (6.76)
Years with HIV-associated diarrhea  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 34 participants 33 participants 103 participants
4.4  (5.4) 6.9  (7.3) 6.6  (6.7) 5.9  (6.54)
Baseline Plasma CD4+ cell count  
Mean (Standard Deviation)
Unit of measure:  Cells/microliter
Number Analyzed 36 participants 34 participants 33 participants 103 participants
629  (307) 746  (324) 671  (319) 682  (317)
Plasma viral load  
Mean (Standard Deviation)
Unit of measure:  copies/mL
Number Analyzed 36 participants 34 participants 33 participants 103 participants
24  (11) 27  (22) 28  (28) 26  (21)
1.Primary Outcome
Title Frequency of Daily Unformed Bowel Movements
Hide Description Change in number of abnormal or unformed stools by week 4
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo SBI 2.5 g SBI 5.0g
Hide Arm/Group Description:
Matching Placebo

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.

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.

Overall Number of Participants Analyzed 36 34 33
Mean (Standard Deviation)
Unit of Measure: abnormal or unformed stools
-2.46  (2.01) -2.16  (2.18) -2.20  (1.99)
2.Other Pre-specified Outcome
Title Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)
Hide Description Lowest baseline CD4+ quartile (less than or equal to 418)
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo SBI 2.5 g SBI 5.0 g
Hide Arm/Group Description:
Matching Placebo

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

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.

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

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.

Overall Number of Participants Analyzed 10 7 8
Mean (Standard Deviation)
Unit of Measure: cells/microliter
-19.8  (59.22) 41.86  (84.83) 47.63  (42.63)
3.Other Pre-specified Outcome
Title Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630
Hide Description 2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo SBI 2.5 g SBI 5.0 g
Hide Arm/Group Description:
Matching Placebo

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

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.

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

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.

Overall Number of Participants Analyzed 13 6 6
Mean (Standard Deviation)
Unit of Measure: cells/microliter
31.46  (122.70) 82.67  (205.16) 12.00  (119.75)
4.Other Pre-specified Outcome
Title Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)
Hide Description 3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo SBI 2.5 g SBI 5.0 g
Hide Arm/Group Description:
Matching Placebo

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

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.

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

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.

Overall Number of Participants Analyzed 1 10 13
Mean (Standard Deviation)
Unit of Measure: cells/microliter
48.00  (NA) 36.70  (183.14) -29.46  (224.83)
5.Other Pre-specified Outcome
Title Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)
Hide Description 4th Baseline CD4+ Quartile (greater than 893)
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo SBI 2.5 g SBI 5.0 g
Hide Arm/Group Description:
Matching Placebo

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

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.

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

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.

Overall Number of Participants Analyzed 10 10 4
Mean (Standard Deviation)
Unit of Measure: cells/microliter
-144.00  (155.15) -54.20  (230.43) -365.25  (464.04)
6.Other Pre-specified Outcome
Title Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sub-study
Arm/Group Title CD4 + T Cell Counts CD8 + T Cell Counts
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8
Mean (Full Range)
Unit of Measure: cells/mm3
144.80
(-107.5 to 324.7)
-67.95
(-339.4 to 187.9)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SBI 2.5 g SBI 5.0g
Hide Arm/Group Description

Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase

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.

Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase

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.

All-Cause Mortality
SBI 2.5 g SBI 5.0g
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SBI 2.5 g SBI 5.0g
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/55 (3.64%)      1/47 (2.13%)    
Injury, poisoning and procedural complications     
Subarachnoid Haemorrhage * 1  0/55 (0.00%)  0 1/47 (2.13%)  1
Nervous system disorders     
Cerebral Haemorrhage * 1  0/55 (0.00%)  0 1/47 (2.13%)  1
Neuropathy Peripheral * 1  1/55 (1.82%)  1 0/47 (0.00%)  0
Psychiatric disorders     
Alcohol Abuse * 1  1/55 (1.82%)  1 0/47 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
SBI 2.5 g SBI 5.0g
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/55 (47.27%)      20/47 (42.55%)    
Gastrointestinal disorders     
Toothache * 1  3/55 (5.45%)  3 1/47 (2.13%)  1
Flatulence * 1  2/55 (3.64%)  2 0/47 (0.00%)  0
Gastritis * 1  2/55 (3.64%)  2 0/47 (0.00%)  0
General disorders     
Nausea * 1  2/55 (3.64%)  2 1/47 (2.13%)  1
Infections and infestations     
Nasopharyngitis * 1  0/55 (0.00%)  0 2/47 (4.26%)  2
Investigations     
Blood Glucose Increased * 1  0/55 (0.00%)  0 2/47 (4.26%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  7/55 (12.73%)  7 3/47 (6.38%)  3
Myalgia * 1  5/55 (9.09%)  5 3/47 (6.38%)  3
Nervous system disorders     
Headache * 1  2/55 (3.64%)  2 2/47 (4.26%)  2
Dizziness * 1  2/55 (3.64%)  2 1/47 (2.13%)  1
Psychiatric disorders     
Anxiety * 1  5/55 (9.09%)  5 1/47 (2.13%)  1
Insomnia * 1  0/55 (0.00%)  0 2/47 (4.26%)  2
Vascular disorders     
Hypertension * 1  0/55 (0.00%)  0 2/47 (4.26%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
If no multi-site publication is made within 18 months, Site may publish Site’s results, subject to the following. At least 30 days prior to submitting a manuscript the Site shall provide to Entera a copy, and Entera shall have 30 days to review. Site shall remove any Confidential Information, upon Entera's request, prior to submitting the materials, and the Site shall delay publication for an additional period of up to 60 days to allow Entera to protect its interests in any Inventions.
Results Point of Contact
Name/Title: Senior Director, Clinical Research
Organization: Entera Health
Phone: 515-963-7565
Responsible Party: Entera Health, Inc
ClinicalTrials.gov Identifier: NCT01828593     History of Changes
Other Study ID Numbers: EH6001
First Submitted: April 8, 2013
First Posted: April 10, 2013
Results First Submitted: February 9, 2016
Results First Posted: March 8, 2016
Last Update Posted: June 21, 2017