CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Serum-derived bovine immunoglobulin protein isolate (SBI) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02017405
NCT02017405N/ACompleted
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A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults

Entera Health, Inc·interventional·Posted Dec 20, 2013·Updated Sep 19, 2024

In Brief

A clinical study evaluating Serum-derived bovine immunoglobulin protein isolate (SBI) and Matching Placebo for Healthy. Completed, enrolled 42 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 20, 2013
Enrollment StartDec 1, 2013
Primary CompletionMar 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.5 years ago

Interventions

Serum-derived bovine immunoglobulin protein isolate (SBI)other

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

Matching Placeboother