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

This study has been withdrawn prior to enrollment.
(Sponsors decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747071
First Posted: September 4, 2008
Last Update Posted: August 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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).

Condition Intervention Phase
Clostridium Difficile-Associated Diarrhea Drug: Colostrum Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Recurrence of active Clostridium difficile associated diarrhea in index cases [ Time Frame: 60 days ]
  • New cases of Clostridium difficile associated diarrhea in close hospital contacts. [ Time Frame: 60 days ]

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

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747071


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Gadi Lalazar MD, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00747071     History of Changes
Other Study ID Numbers: 0180-08-HMO - CTIL
First Submitted: September 3, 2008
First Posted: September 4, 2008
Last Update Posted: August 28, 2012
Last Verified: June 2011

Keywords provided by Hadassah Medical Organization:
Clostridium difficile
diarrhea
colostrum

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs