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NCT01828593 · ClinicalTrials.gov registry record · NA
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
A NA study, sponsored by Entera Health.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT01828593: Completed NA study, sponsored by Entera Health.
NCT01828593 is a NA study that has completed, run by Entera Health. The registered enrollment target is 103 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01828593, a NA study, has completed, sponsored by Entera Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
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 twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
Primary Outcome
Change in number of abnormal or unformed stools by week 4
Interventions
- OTHER Placebo
- OTHER Serum-derived bovine immunoglobulin protein isolate (SBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-09 |
| Phase | NA |
What the finished NCT01828593 record still lists
NCT01828593 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01828593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01828593 about?
NCT01828593 is a clinical study titled "Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy". 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 twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
What is the current status of trial NCT01828593?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2013-04. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01828593?
The interventions under investigation include: Placebo (OTHER), Serum-derived bovine immunoglobulin protein isolate (SBI) (OTHER).
Who is sponsoring clinical trial NCT01828593?
This trial is sponsored by Entera Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01828593's enrollment target sits among peer trials
103 837th of 2000 higher than 1,164 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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