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NCT02730325 · ClinicalTrials.gov registry record · NA

To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients

A NA study, sponsored by Northwestern University.

Terminated
Registry status
NA
Development phase
10
Enrollment target

NCT02730325: Clinical Trial NA study, sponsored by Northwestern University.

NCT02730325 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02730325, a NA study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations: I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are receiving vancomycin. II. Hospitalized UC patients who tested negative for C. difficile at time of admission.

Primary Outcome

Group 1 \& Group 2 subjects: Stool consistency will be assessed using the BSS. Subjects will be provided a daily diary A to record the time and consistency of each bowel movement in a 24 hour period. At the Week 4 visit, the Investigator will calculate the time (# of days) to resolution of diarrhea, defined as a consecutive 24 hour period with only formed bowel movements (BSS ≤ 4), after initiation of investigational product (Day 1).

Interventions

  • OTHER Placebo
  • OTHER Serum-derived bovine immunoglobulin/protein isolate (SBI)

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-12
Est. Completion 2018-01-05
Phase NA
Northwestern University

1,209 total trials

Why NCT02730325 stopped before completion

NCT02730325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02730325 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02730325 about?

NCT02730325 is a clinical study titled "To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients". The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations: I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are...

What is the current status of trial NCT02730325?

This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2015-12. Estimated completion is 2018-01-05.

What interventions are being tested in trial NCT02730325?

The interventions under investigation include: Placebo (OTHER), Serum-derived bovine immunoglobulin/protein isolate (SBI) (OTHER).

Who is sponsoring clinical trial NCT02730325?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02730325's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 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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Source: ClinicalTrials.gov NCT02730325, the US trial registry maintained by the National Library of Medicine. NCT02730325 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.