Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

August 27, 2012 updated by: Hadassah Medical Organization
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Hospitalized patients with Clostridium difficile associated diarrhea.
Drug: Colostrum
Daily administration of Colostrum derived antibodies against C. difficile.
Experimental: 2
Close hospital contacts of each index case
Drug: Colostrum
Daily administration of Colostrum derived antibodies against C. difficile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of active Clostridium difficile associated diarrhea in index cases
Time Frame: 60 days
60 days
New cases of Clostridium difficile associated diarrhea in close hospital contacts.
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease severity - duration, maximal intensity (number of stools) in index cases.
Time Frame: 60 days
60 days
Eradication of Clostridium difficile from stools
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0180-08-HMO - CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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