NCT00747071

Brief Summary

This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
3 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 28, 2012

Status Verified

June 1, 2011

Enrollment Period

1.2 years

First QC Date

September 3, 2008

Last Update Submit

August 27, 2012

Conditions

Clostridium Difficile-Associated Diarrhea

Keywords

Clostridium difficilediarrheacolostrum

Outcome Measures

Primary Outcomes (2)

  • Recurrence of active Clostridium difficile associated diarrhea in index cases

    60 days

  • New cases of Clostridium difficile associated diarrhea in close hospital contacts.

    60 days

Secondary Outcomes (2)

  • Disease severity - duration, maximal intensity (number of stools) in index cases.

    60 days

  • Eradication of Clostridium difficile from stools

    1 year

Study Arms (2)

1

EXPERIMENTAL

Hospitalized patients with Clostridium difficile associated diarrhea.

Drug: Colostrum

2

EXPERIMENTAL

Close hospital contacts of each index case

Drug: Colostrum

Interventions

ColostrumDRUG

Daily administration of Colostrum derived antibodies against C. difficile.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Written informed consent
  • At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
  • Confirmed diagnosis of C. difficile associated diarrhea

You may not qualify if:

  • Pregnant or breast feeding women
  • Known allergy to milk or milk products
  • Other etiology of diarrhea
  • Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
  • Pseudomembranous colitis
  • White blood count \> 50,000
  • Blood in stools
  • Laxatives or motility drugs within 12 hours
  • Inability to participate in adequate follow up
  • Clinically unstable
  • Investigator deems unsuitable
  • Immune suppression (disease or treatment)
  • GI surgery
  • Past intestinal parasites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 4, 2008

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

August 28, 2012

Record last verified: 2011-06

Locations

IL(1)