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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00747071
First received: September 3, 2008
Last updated: August 27, 2012
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • New cases of Clostridium difficile associated diarrhea in close hospital contacts. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease severity - duration, maximal intensity (number of stools) in index cases. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Eradication of Clostridium difficile from stools [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747071

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

No publications provided

Responsible Party: Gadi Lalazar MD, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00747071     History of Changes
Other Study ID Numbers: 0180-08-HMO - CTIL
Study First Received: September 3, 2008
Last Updated: August 27, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Clostridium difficile
diarrhea
colostrum

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

ClinicalTrials.gov processed this record on May 23, 2013